Tag: Tests (Medical)

What to Know About Testing and Vaccine Requirements for Travel

Do you need to be vaccinated or have a negative Covid-19 test for your next trip? Check this guide before traveling domestically or abroad.

As vaccinations ramp up and regulations loosen for people in the United States, many are planning travel for summer and beyond, with experts predicting that July 4 will be the biggest travel weekend since the beginning of the pandemic.

But with regulations shifting, people might have questions about testing or vaccination requirements for their trips. The Centers for Disease Control and Prevention recently eased travel recommendations to more than 100 countries. Some countries are completely open to vaccinated travelers, while others require a negative coronavirus test result in order to enter.

In the United States, the C.D.C. has advised that vaccinated people no longer need to wear masks in most places and released new travel guidelines that said domestic travel is safe for them. But travelers must take note of local advice and regulations, as these can vary state by state.

Here’s everything you need to consider about testing and vaccinations before you travel within the U.S. or internationally.

Are there testing and vaccination requirements for domestic travel?

For most places, no. You do not need to be vaccinated for any domestic travel. Hawaii is the only state that requires a negative test for travel.

In Hawaii, the test must be administered within 72 hours of arrival and the results uploaded to its Safe Travel platform to avoid a mandatory quarantine when entering the state or for some inter-county travel, though the latter restrictions are set to end on June 15.

Alternatively in Hawaii, you can also provide proof that you’ve recovered from Covid-19 in the past 90 days, including both a positive test result and a letter from a doctor clearing you to travel.

The state’s governor, David Ige, said this month that people who received their vaccination in the state of Hawaii may bypass testing and quarantine requirements starting on June 15, and that anyone vaccinated in the U.S. will be able to enter Hawaii without testing once the state has reached a 60 percent vaccination rate.

If you are unvaccinated, you should continue to adhere to social distancing and mask-wearing protocols while traveling domestically, the C.D.C. said. You can use the C.D.C.’s Travel Planner to check guidelines by state.

What are the testing and vaccination rules for international travel?

While testing and vaccination requirements vary by destination country, everyone arriving in the U.S. — even vaccinated Americans — must present a negative test result upon entry.

Many nations are still closed to American travelers. Those that are open may require a negative test, proof of vaccination or evidence of recovery (or a combination of these) to enter.

The United Kingdom, for instance, requires that American travelers, regardless of vaccination status, provide proof of a negative test taken within 72 hours of departure, quarantine upon arrival and take two additional tests during their stay. Children under 11 are exempt from these requirements, as are some other people depending on their reason for travel.

Some European countries are allowing in Americans who are vaccinated or who can show a negative test, with more expected to follow suit.

Canada is still closed to Americans, with few exceptions, and will remain so until at least early July, said Patty Hajdu, the country’s minister of health, in a news conference in June.

The U.S.-Mexico land border is closed for nonessential travel until at least June 21, but air travel is allowed and the country does not require a negative test for entry. Because of its high risk level, the C.D.C. recommends that travelers be fully vaccinated before traveling to Mexico.

Consult the C.D.C.’s inventory of international travel health notices for more information on regulations by country.

“Travelers should always check with their airline and the embassy of the country they are visiting to ensure they have the proper documentation required to enter the country,” said Perry Flint, a spokesman for The International Air Transport Association, a global airline industry group.

What test should I take, and where and when?

To enter the U.S., travelers must show a negative result to a nucleic acid amplification test (NAAT) — PCR is a type of NAAT test — or an antigen test, also known as a rapid test, taken in the three days before departure, according to the C.D.C.

Some airports offer on-site testing, such as Heathrow Airport in England, or Rome’s Fiumicino International Airport in Italy.

Josh Alexander, a New York-based luxury travel agent for Protravel International, said that many international hotels, including most Four Seasons hotels and resorts, are offering on-site rapid tests for free or at a nominal cost.

Testing at local clinics is also available in many places, though you should check availability at your destination ahead of time and book if you can. It may also come at a high cost. Mr. Alexander said that PCR tests abroad can range from $50 to $150.

The C.D.C. said that it allows for a three-day time frame rather than 72 hours to allow flexibility in the time of day the test can be taken. For instance, if you are flying out on a Friday, the test may be taken at any time on Tuesday.

But, when it comes to international destinations, Mr. Alexander recommends erring on the side of caution when timing your test by calculating it based on time of arrival at your destination.

“Rules are constantly changing,” he said, “so we’re just trying to always tell people they should always be as conservative as possible to eliminate any gray area.”

What are the requirements for minors?

The C.D.C. testing recommendations apply to all children 2 years and older, which means your toddler also needs to deliver a negative Covid-19 test to enter the U.S. from abroad. When traveling, children should wear masks, practice social distancing and wash hands often, the C.D.C. said.

“If the kids are age 12 and older, get ’em vaccinated,” said William Schaffner, an infectious disease expert at Vanderbilt University, in an email.

If you’re traveling to a country within the European Union that is open to travelers from the U.S., children who cannot be vaccinated should have a negative PCR test taken no more than 72 hours before arrival at your destination, and additional testing may be required upon arrival.

Travelers should check with their airline or destination country website for relevant requirements.

What if I want to go on a cruise?

Rules vary from one cruise line to another, with some planning to require that all passengers and crew be vaccinated, and others adopting a hybrid model.

But recent laws passed in Florida and Texas banning businesses from requiring proof of vaccination to use their services may complicate this plan.

Celebrity Cruises, set to be the first U.S. cruise ship to restart operations on June 26 from Fort Lauderdale, Fla., said it’s optimistic that a resolution would be reached in time. It is requiring that guests 16 years and older be vaccinated, while children will be tested at the terminal.

Carnival Cruises said on Monday that its first ship would set sail from the Port of Galveston, in Texas, on July 3 and would be available only for vaccinated passengers. Norwegian, which will begin to operate cruises from Miami in August, said it will require the same through October 31 and has threatened to skip Florida ports if the state does not allow cruise lines an exemption from the law banning vaccine requirements.

Christine Duffy, the president of Carnival Cruise Line, said in a statement on June 7 that “the current CDC requirements for cruising with a guest base that is unvaccinated will make it very difficult to deliver the experience our guests expect, especially given the large number of families with younger children who sail with us.”

“As a result, our alternative is to operate our ships from the U.S. during the month of July with vaccinated guests,” she said.

But even if you are vaccinated, you must also consider the requirements of the country where the cruise is disembarking. The Caribbean island of St. Maarten, for instance, where Celebrity Cruises started sailing on June 5, requires a negative test in addition to proof of vaccination.

What documents should I bring with me if I travel?

This will also depend on where you’re going, but a good rule of thumb is to carry your physical vaccine card, if you have it, and proof of a negative test, if it is required.

Mr. Alexander, the travel agent, recommends people bring the original documents. While a number of digital health certificates — which show vaccine status and test results — are in the works, he said, they are not yet widely accepted. You should check, also, that your document is in the correct language. The United Kingdom, for instance, requires that test results be in English, Spanish or French.

CommonPass, from the Geneva-based nonprofit the Commons Project Foundation, and the I.A.T.A. Travel Pass are two apps providing digital access to vaccine and testing records for travel. The European Union will be releasing its own digital Covid certificate for E.U. citizens by July 1, though it is unclear whether Americans will be able to use it.

You should check with your airline to see if the app you want to use will be accepted at your destination. Both the CommonPass and I.A.T.A. websites list destinations and airline partners accepting the digital health certificates.

Mr. Alexander added that some countries, such as Croatia, may also require proof of a return flight or confirmation of your hotel booking or other accommodation, though this is rare. In South Africa, which has implemented a curfew, travelers may need to show their flight ticket to law enforcement officers to show they are allowed to be in transit.

But these shifting regulations should not dissuade people from traveling, Mr. Alexander said.

“If you’re vaccinated and you’re following safe precautions, you can still have a great experience,” he said.

Can a Smartwatch Save Your Life?

The advent of wearable devices that monitor our heart rhythms both excites and worries doctors.

Cinemagraph
By Sean Dong

On a recent Saturday, my 87-year-old mother was feeling a bit woozy, so she pressed a button on the side of her Apple watch to reveal her ECG, a recording of her heart’s electric rhythm. Thirty seconds later, three messages appeared on the watch’s screen. One showed the characteristic zigzag spikes of the ECG, or electrocardiogram. The second revealed that her heart rate, usually 80 beats per minutes, was down to only 40. The third said the results were “inconclusive,” with the advice: “Call your doctor.”

My mother is a hardy octogenarian. She walks about a mile every day, works out with a trainer (currently via Zoom) three times a week and, as she often used to say, planks nearly as well as her former sorority sister, the late Ruth Bader Ginsburg.

After leaving a message with her doctor’s office, she called my brother, a doctor who lives nearby, and told him she was exhausted and “just not feeling right.” He came over immediately and took her to the emergency room.

There, the hospital’s electrocardiogram, which provides a more detailed readout than the watch, showed that the electrical signals in the top part of the heart were not being transmitted properly to the bottom. Her heart was beating, but too slowly. The staff rushed her to the cardiac care unit, where doctors implanted a pacemaker the next morning.

When she called a longtime friend to tell her the story, the friend responded that she’d likewise had a recent smartwatch scare: her heart rate was sky-high, reaching 182. Her doctor had her wear a Holter monitor, a medical-grade portable ECG device that monitors heart rhythm continuously, for four days and advised her to keep a diary of symptoms, such as chest pain or a skipped heartbeat. She didn’t notice any, and the report from the Holter device revealed that everything was fine.

The advent of smartwatches that retrieve heart physiology both excites and worries physicians. In addition to Apple, a number of companies make wearable E.C.G. monitors for home use, including Samsung, Withing, Fitbit and AliveCor. And for every story like my mother’s, in which a warning leads to the placement a potentially lifesaving pacemaker, there are many more like her friend’s, in which minor variations in heartbeats lead to needless work-ups, treatments with risky side effects and lots of unnecessary anxiety.

So are these wearables worth it?

Conclusive evidence about their accuracy and cost effectiveness is lacking, though an Apple-sponsored study from 2019 published in The New England Journal of Medicine suggested they may help to detect some kinds of abnormal heart rhythms, particularly in the elderly. A slew of additional studies are underway, including ones to assess whether a smartwatch can actually help to save lives, or whether mobility measures such as step count lead to fewer heart attacks and hospitalizations.

Most of these at-home E.C.G. watches are designed to record heart rate and detect atrial fibrillation, the most common irregular heart rhythm, which affects up to six million Americans. A-fib, as it’s called, increases the risk of strokes, leading to 150,000 deaths and 450,000 hospitalizations a year. But doctors say that many people have an irregular heartbeat every now and then that doesn’t have clinical implications.

Like many new technologies that uncover things in the body that doctors don’t yet fully understand, these devices may alert the user about an irregular heartbeat, but not all irregularities are dangerous. “It’s like we just invented the microscope and are seeing microorganisms, and we don’t know what they are,” said Dr. Harlan Krumholz, director of the Center for Outcomes Research and Evaluation at Yale. “We are seeing things, and we aren’t sure if it denotes extra risk.”

Most watches wait to send an alert until there have been about five abnormal beats within an hour or so, rather than after every altered rhythm. Still, that doesn’t mean the abnormality is dangerous.

“As a cardiologist, I really like at-home devices,” said Dr. Gary Rogal, medical director of cardiovascular services at RWJBarnabas Health in West Orange, N.J., whose team cared for my mother. But he clarified he likes them only for patients in whom he feels there’s an indication to look for something, such as those with an existing heart condition or a family history of heart disease. “I would never subscribe to the concept that everyone should be monitored. You’ll see stuff and it will make you crazy, but you’re probably fine.”

The American Heart Association agrees that smartwatch monitors could be beneficial, even lifesaving, for some, but Dr. Mariell Jessup, the group’s chief science and medical officer, said, “we do not have enough data yet to recommend it for everyone.”

Even electrocardiograms performed at a doctor’s office aren’t routinely recommended for everyone. The U.S. Preventive Services Task Force, a group of experts that advises on screening tests, says there is not enough evidence to show that routine ECGs are effective and worries about the costs, and potential dangers, of further testing.

And doctors worry that as more and more people wear these devices that might spot meaningless heart arrhythmias, there could be a flood of unnecessary follow-up testing and too much treatment.

“That’s what keeps me up at night,” said Dr. Joseph Ross, a professor of medicine and public health at Yale who is among a team of investigators conducting a randomized clinical trial that compares a group wearing the Apple watch to a control group wearing a smartwatch without the E.C.G. app. “If someone with an occasional abnormal rhythm that would never have caused a stroke undergoes an extensive work-up or is put on a blood thinner, the risk of a dangerous bleed or other harm outweighs the benefits of potentially preventing a stroke.”

Dr. Steven Lubitz, an associate professor of medicine at Harvard Medical School and cardiologist at Massachusetts General Hospital, fears that customers will think the watches provide a safeguard for overall heart health and assume, for example, they check for signs of heart attacks, which they do not.

“Your mother’s story is the hope for all of these devices. In her case, the technology led to a diagnosis of a dangerously slow heart rate,” he said. “To date, most of the tech work on heart rate has been focused on detecting A-fib. Similar rigor may be required to validate the detection of other health conditions.”

We may be on the verge of entering a new era of medicine in which patients can glance at their wrists to check their emails and heart rhythms and notify their physicians if something seems awry. In the perfect health care world, cardiologists envision a day where they can prescribe a watch or other small clip-on device to high-risk patients and insurance would cover the cost. Otherwise, the advent of new technology would only help those who can afford it, exacerbating health inequities.

As Dr. Ross noted, “I want to see more scrutiny, to know whether these digital devices that consumers can purchase are making our patients’ lives better.”

Two weeks after her surgery, my mother was doing her one-minute planks and lifting weights with her Zoom personal trainer. Maybe, without the watch, my mother would have been OK and just felt really tired until she called her doctor on Monday. Or maybe not.

Is It Covid or the Flu? New Combo Tests Can Find Out.

New tests for respiratory illnesses can look for more than 20 pathogens at a time.

In January, a man in his 60s with heart disease and diabetes went to a South Dakota hospital with a cough and fever, worried he had Covid. A nurse swabbed the inside of his nose, and the sample went into a small device resembling an inkjet-printer cartridge, which was then placed into a machine about the size of a printer.

This so-called quad test, now available at thousands of hospitals and clinics around the country, could detect not only the coronavirus, but two types of influenza and the respiratory syncytial virus, or R.S.V. A little more than a half-hour later, Dr. Blake Gustafson had the patient’s result: He had the flu.

“I remember giving myself a fist bump like, ‘Yes! It’s not Covid. It’s the flu,’” said Dr. Gustafson, chief of emergency medicine of the Sanford USD Medical Center in Sioux Falls, S.D. He relayed the news to the patient and his wife, happily adding that there was a treatment he could offer right away, Tamiflu. “The relief in their eyes above their masks was very satisfying,” Dr. Gustafson said.

The patient’s situation was somewhat unusual this past winter given that the United States, like many other countries, witnessed a shocking absence of a flu season. But as the country begins to reopen, doctors say that flu and other pathogens might make a comeback this autumn. What’s more, even as a growing number of people get vaccinated against Covid, there are still some 40,000 new infections every day in the United States, and a significant number of people who may be resistant to taking the vaccines.

The Sanford Health system, which includes 46 hospitals and 1,400 physicians in South Dakota, carries out 600 to 800 tests for the coronavirus a day in its clinics using antigen tests, which detect proteins made by the virus. But according to Rochelle Odenbrett, the senior executive director of laboratories, the organization is now in the process of replacing all of those tests with the quad tests used in its emergency settings.

Unlike the antigen tests, the quad test looks for a virus’s genetic material using a polymerase chain reaction, or P.C.R. for short. The P.C.R.-based method is far more accurate than the antigen approach, Ms. Odenbrett says. She notes that P.C.R. sequencing of patient samples used to be more cumbersome and relied on multistep procedures across different laboratory rooms. “It’s just amazing how the technology has evolved,” she said.

Rochelle Odenbrett, senior executive director of laboratories at Sanford Health. “It’s just amazing how the technology has evolved,” she said.
Rochelle Odenbrett, senior executive director of laboratories at Sanford Health. “It’s just amazing how the technology has evolved,” she said.Sanford Health

The quad test used by the Sanford system is made by the California-based company Cepheid, which received emergency authorization from the Food and Drug Administration in late September.

Although last year’s flu season was nonexistent, Dr. Geoffrey Baird of the University of Washington in Seattle said that a confluence of factors might precipitate its return in the fall: children returning to school buildings, declining use of masks and perhaps a lack of recent immune system exposure to the flu. If more people get sick in the fall, he added, they will want to know if it is flu or the coronavirus.

“We in the laboratory are preparing for another big boom in testing,” said Dr. Baird, whose team has run more than two million coronavirus tests since the beginning of the pandemic. “Even if people are vaccinated, they’re going to wonder, ‘Am I the breakthrough case?’”

In addition to Cepheid, other companies have developed tests that look for influenza and the coronavirus at the same time, including Roche, which has received emergency use authorization for a test that looks for the coronavirus, influenza A and influenza B at once.

In recent years various hospitals have developed in-house versions of these combination tests as well, some of which look for more than a dozen different respiratory pathogens simultaneously using P.C.R. technology. Those “multiplex” tests are especially helpful in diagnosing illnesses in people with weak immune systems because they allow doctors to swiftly discern what pathogen is making a person sick before it is too late to start the right treatments.

A French company, bioMérieux, sells a P.C.R. test that looks for the coronavirus as well as 21 other viruses and bacteria simultaneously. And Roche recently bought a company that sells a machine that can screen for more than 20 pathogens in one go.

Testing for multiple pathogens does not always lead to a simple treatment, however. Co-infections, in which a person is infected with multiple viruses simultaneously, are more common than doctors expected, and sometimes the multiplex tests might detect a viral infection but miss a bacterial one, said Dr. Daniel Griffin, chief of infectious diseases at ProHealth New York. A patient could carry the influenza virus but also test positive for a bacterium such as pneumococcus, for example.

“We initially thought that every time we identified a virus, we would just be able stop all antibiotics and just treat the virus if effective antiviral therapy was available,” Dr. Griffin said. “We now know that we often need to continue antibiotics,” he explained, because sometimes the multiplex tests are not sensitive enough to rule out a bacterial culprit.

Doctors and test developers are still grappling with how many pathogens to test patients for in different settings. “A burning question at every company is what panel is best — is it one, two, four, 20?” said Dr. Mark Miller, chief medical officer at bioMérieux. Relatively young and healthy adults might just need a quad test to know if they should start on Tamiflu for influenza, for example, but patients with underlying chronic diseases who are very sick might benefit from receiving the test for 22 different pathogens so that doctors can decide whether they need to be admitted to a hospital.

Before the pandemic, people were not always as curious to know the exact pathogen causing respiratory symptoms, according to Dr. Alexandra Valsamakis, head of clinical development and medical affairs at Roche Diagnostics Solutions.

“I think there was always this perception of ‘Oh, whatever it is, it’s not going to kill us,’” Dr. Valsamakis said. But the terrible toll of Covid-19 has changed that. “There’s this need to actually know what’s there, more than there ever was before.”

What the Coronavirus Variants Mean for Testing

Most tests should be able to detect the variants of concern, but test developers and health officials must remain vigilant, scientists say.

In January 2020, just weeks after the first Covid-19 cases emerged in China, the full genome of the new coronavirus was published online. Using this genomic sequence, scientists scrambled to design a large assortment of diagnostic tests for the virus.

But the virus has mutated since then. And as the coronavirus has evolved, so has the landscape of testing. The emergence of new variants has sparked a flurry of interest in developing tests for specific viral mutations and prompted concerns about the accuracy of some existing tests.

“With these Covid diagnostics, we were on a time crunch, we had to get something out there,” said Lorraine Lillis, the scientific program officer at PATH, a global health nonprofit that has been tracking coronavirus tests. “Normally, diagnostics take a long, long time, and we’d normally challenge them with multiple variants.” She added: “And we’re doing that, but we’re doing it in real time.”

The Food and Drug Administration has warned that new mutations in the coronavirus could render some tests less effective. And last week, PATH launched two online dashboards to monitor how certain variants might affect the performance of existing diagnostic tests.

So far, scientists have agreed, there is no evidence that the known variants of concern are causing tests to fail completely. “The tests today work very, very well,” said Mara Aspinall, an expert in biomedical diagnostics at Arizona State University.

But manufacturers and regulators will need to remain vigilant to ensure they keep pace with a constantly changing virus, scientists say. If variants begin to evade detection, that could be consequential not only for individual patients, who may not receive the treatment they need, but also for public health.

If a test misses someone who is infected by a variant, then that person may not realize they need to isolate. “And that person is allowed then to be unquarantined, to circulate in the community and possibly spread that variant to others,” said Gary Schoolnik, a physician and infectious disease expert at Stanford University and the chief medical officer of Visby Medical, a diagnostics company that makes a Covid-19 test. “And that’s how a diagnostic test, if it’s missing variants, can actually promote the spread of that variant.”

The risk of false negatives

Processing swab samples for rapid antigen tests at a testing site in San Francisco last month.
Processing swab samples for rapid antigen tests at a testing site in San Francisco last month.Mike Kai Chen for The New York Times

Molecular tests, like the widely used polymerase chain reaction, or P.C.R., test, are designed to detect specific sequences of the coronavirus genome. If mutations appear in these “target” sequences, the tests may no longer be able to detect the virus, yielding false negatives.

“You could run into a situation where you just got unlucky with where you chose to target your test, and something popped up there that then made your test less effective,” said Nathan Grubaugh, a virologist at Yale University.

The gene for the virus’s characteristic spike protein, known as the S gene, has been particularly prone to mutation, and tests that target this gene may miss certain variants. For instance, Thermo Fisher’s TaqPath test fails to detect the mutated S gene of the B.1.1.7 variant, which was first identified in Britain and is now spreading rapidly through the United States.

But the test does not rely on the S gene alone; it has three targets and can still return accurate results by detecting two other stretches of the coronavirus genome.

Just 1.3 percent of molecular tests rely solely on an S gene target, according to calculations performed by Rachel West, a postdoctoral associate at the Johns Hopkins Center for Health Security. The rest either target more stable regions of the genome, which are less likely to mutate, or have multiple target sequences, which makes them less susceptible to failure. “It’s very unlikely that you’re going to get mutations in all of them,” Dr. Lillis said.

The F.D.A. has listed four different molecular tests “whose performance could be impacted” by the variants, but notes that the tests should still work. Three of the tests have multiple targets; a fourth may be slightly less sensitive when the virus has one particular mutation and is present at very low levels. (The four tests are the TaqPath Covid-19 Combo Kit, the Linea Covid-19 Assay Kit, the Xpert Xpress and Xpert Omni SARS-CoV-2, and the Accula SARS-CoV-2 Test.)

“We don’t think that those four assays are significantly impacted,” said Dr. Tim Stenzel, who directs the F.D.A.’s office of in vitro diagnostics and radiological health. “It was more out of an abundance of caution and transparency that we made that information public.”

Antigen tests are less sensitive than molecular tests, but they are typically cheaper and faster, and they are being deployed widely in coronavirus screening programs. These tests detect specific proteins on the outside of the virus. Some genetic mutations could change the structure of these proteins, allowing them to escape detection.

Most antigen tests target the nucleocapsid protein. The gene that codes for this protein, known as the N gene, is more stable and less likely to mutate than the S gene, and the F.D.A. has not listed any antigen tests as being of concern. “We haven’t found one that raises a red flag nor have we had any reports of such,” Dr. Stenzel said.

Still, experts note, not every test manufacturer discloses the specific sequences that their tests target, and the virus will continue to mutate. “There hasn’t been any evidence to show that a particular molecular assay or even an antigen test completely misses the boat in terms of detection,” said Neha Agarwal, the associate director of diagnostics at PATH. “But things are going to change.”

The F.D.A. is continuing to monitor the situation, checking coronavirus sequence databases weekly to see if the virus is evolving in ways that may help it evade diagnostic tests. “We’re being very vigilant,” Dr. Stenzel said. “And we will stay vigilant.”

Screening for specific variants

Covid-19 test samples in a lab at Duke University in February. Positive specimens undergo genomic sequencing, to identify the specific variant.Pete Kiehart for The New York Times

As the variants spread, researchers are also working to develop and improve tests to detect them. At the moment, identifying a variant is typically a two-step process. First, a standard coronavirus test, like a P.C.R. test, is used to determine whether the virus is present. If the test comes back positive, a sample is then sent for genomic sequencing.

“These two tasks are currently done in two separate workflows,” said Juan Carlos Izpisua Belmonte, a developmental biologist at the Salk Institute in La Jolla, Calif. “This means more time, labor and resources.”

Many researchers are now working to create integrated solutions — tests that can determine both whether someone is infected with the virus and whether they might have a particular variant.

For instance, in a recent paper, Dr. Izpisua Belmonte and his colleague, Mo Li, a stem cell biologist at King Abdullah University of Science and Technology in Saudi Arabia, described a new testing method that can identify mutations in up to five different regions of the coronavirus genome.

And Dr. Grubaugh and his colleagues have developed a P.C.R. test that can detect specific combinations of mutations that characterize three variants of concern: B.1.1.7; B.1.351, which was first detected in South Africa; and P.1, first found in Brazil. (The work has not yet been published in a scientific journal.)

Dr. Grubaugh said that researchers in Brazil, South Africa and elsewhere are already using the tests to sift through a mountain of coronavirus samples, identifying those that should be prioritized for full genomic sequencing. “Our group’s primary interest is enhancing genomic surveillance through sequencing, especially in resource-limited areas,” Dr. Grubaugh said. “If you want to know if there’s variants that are circulating, you need a way to triage.”

A number of companies are also beginning to release coronavirus tests that they say can differentiate between certain variants, although these are intended for research purposes only. Creating a test that can definitively diagnose someone with a particular variant is “infinitely harder,” Dr. Grubaugh said.

Similar mutations are springing up in different variants, which makes distinguishing among them more difficult. The mutations of interest will change as the virus does, and sequencing remains the best way to get a complete picture of the virus.

But tests that can screen for certain mutations could be an important public health tool, Ms. Agarwal said: “These newer diagnostics that are looking across the variants, I think will be really key in understanding the epidemiology of the virus and planning our next generation of efforts against it.”

Breast Cancer Centers Urge Annual Scans, Counter to U.S. Guidelines

A panel recommends biennial screenings, starting at 50, but a new study took issue with the way hundreds of centers are telling women 40 and up to come in yearly. Some experts contend that frequent mammograms can “do more harm than good.”

My last breast cancer screening was “b.c.” — before Covid — just a few weeks before the mysterious new disease was detected in China. The timing was perfect: Everything was normal, and by the time we went into lockdown, my to-do list no longer included a mammogram.

But by November 2020, exactly one year after that scan, I started getting barraged by phone calls and text messages telling me I was due for another one.

“MAMMO MATTERS,” screamed one in all capital letters. “Breast cancer does not take a break during pandemics, and neither should you.” I was well aware that national health guidelines recommend a mammogram only every other year for women at average risk for breast cancer. But there has been a cacophony of advice in recent years as different groups recast their recommendations, often contradicting one another. So the messages were unnerving.

It turns out my imaging center is not alone in badgering women to have mammograms more frequently than the U.S. Preventive Services Task Force deems optimal. A recent study found that hundreds of breast centers tell women who are not at elevated risk of cancer to have a routine scan every year, and to start at 40.

The task force, however, recommends regular mammograms every two years starting at 50. Its guidelines do recommend that women in their 40s discuss mammography with their doctors, evaluate the risks and benefits and come to an individual decision. (The panel’s recommendations extend to age 74; it has said there is not enough evidence to make recommendations past that age.)

The new study, published in JAMA Internal Medicine on March 15, was accompanied by a rather scathing editorial that said extra screening can do “more harm than good.”

“I don’t think breast cancer centers that have clear financial benefits from increasing mammography should be the ones that are giving out patient advice, particularly when it conflicts with the patient’s primary care provider’s advice and the task force’s advice,” said Dr. Rita F. Redberg, editor in chief of JAMA Internal Medicine, who co-wrote the editorial along with Dr. Anand R. Habib and Dr. Deborah Grady.

The American College of Radiology took umbrage, shooting back that it was “outrageous” to assert that breast cancer centers were promoting mammograms for financial reasons, and that the radiologists’ had a different set of guidelines.

When the pandemic started, both routine screenings and appointments triggered by troubling symptoms like the discovery of a lump were delayed as facilities shut down. Even when they reopened, many patients were reluctant to go in.

But Dr. Dana Smetherman, who chairs the American College of Radiology’s breast imaging commission, said the breast centers’ recommendations for more frequent screening predate the pandemic.

“What this study is telling us is that the experts in breast cancer in the U.S. do not support these recommendations,” Dr. Smetherman said in an interview, referring to the U.S. task force’s guidelines.

Indeed: Both the college of radiology and the American Society of Breast Surgeons recommend annual mammograms starting at age 40 (Dr. Redberg’s institution, the University of California, San Francisco, also recommends that schedule).

The American Cancer Society scaled back its recommendations recently, however, endorsing yearly scans starting at age 45, with the option of switching to every other year at age 54. The American College of Obstetricians and Gynecologists recommends women at average risk start mammography at 40, but “every one or two years.”

The debate over screening frequency for breast cancer — the second leading cause of cancer death for women after lung cancer — dates back to 2009. That is when the U.S. Preventive Services Task Force, an independent expert panel that reviews the evidence and provides guidance to doctors and insurers, rolled back its mammography recommendations for women who were deemed at average risk for breast cancer.

Screening can actually be harmful, especially for younger women, the panel found. False positive findings can trigger unnecessary procedures like biopsies, or lead to what experts call over-diagnosis — the aggressive treatment of slow-growing tumors that might never become life-threatening, but cannot be distinguished from fast-growing tumors.

When women had mammograms every other year, the harms of false positives and unnecessary treatment were reduced, the panel determined, while it found the life-saving benefits remained relatively unchanged.

But some experts believe the panel overstated the harms of more frequent screenings. The appropriate schedule for screenings can vary from doctor to doctor, and patient to patient, and has become quite confusing.

“Many women may not even be aware of the guidelines, or that there may be any downside to mammography, and that they have the option to begin screening at age 45 or 50,” Dr. Jennifer L. Marti, an assistant professor of surgery at Weill Cornell Medicine who led the new study, said in an interview. “In almost every other country, women start at 50.”

While many women might assume that “the pros of breast cancer screening outweigh the harms,” Dr. Marti said, that is not always the case for women who aren’t at elevated risk.

Dr. Marti and her co-authors, Mark Lee and Neal Patel, two Weill Cornell researchers, decided to examine the recommendations posted on the websites of some 606 breast cancer centers in the United States. They found that 376 centers — over half — made recommendations that differed from those of the U.S. task force, saying women at average risk for breast cancer should start imaging at age 40.

And 347 centers said women should not only start at 40, but continue annually.

More rigorous screening may be appropriate for some high risk groups, like Ashkenazi Jewish women, who are more likely to carry mutations that put them at risk for breast and ovarian cancer, and Black women, who were likely underrepresented in mammography screening trials, Dr. Marti said.

Women who want help assessing their individual risk to make screening decisions can use an online tool developed by Dr. Margaret Polaneczky, a gynecologist from Weill Cornell Medicine, and Elena Elkin, a research scientist at Memorial Sloan Kettering Cancer Center, Dr. Marti suggested.

As for myself, I’ve been on a two-year plan for a while. I do regular breast self-examinations, and have clinical breast exams too. So even though I felt a smidgen of irrational guilt after receiving the text messages, I politely asked a receptionist to please stop calling. I promised I’d be in touch.

Why I Gave My Mosaic Embryo a Chance

‘It was like rolling the dice, except for someone you’ve never met.’

My husband and I were sitting in an Upper East Side office with deep-toned velvet couches and fluffy throw pillows, surrounded by photos of smiling babies, as the fertility doctor gave his spiel. He told us that after age 35, a woman’s chances of getting pregnant drop. Older women produce few normal embryos even with fertility treatment. But we’d have a healthy baby in our arms within a year — if we tested the embryos.

By testing the chromosomes in my embryos, he said, we could weed out the abnormal embryos that may lead to miscarriage or a child with disabilities and only use viable ones.

I’ve always been a late bloomer — I met my husband at 37 and married at 39. I was in good health but pushing 40, with diminishing egg count and quality. After six months of trying to conceive on our own, we wanted all the help we could get. My husband and I jumped at the embryo testing suggestion.

After two long rounds of in vitro fertilization, we had five embryos, but the genetic testing deemed four of them “abnormal,” meaning they contained extra or missing chromosomes. Our fifth embryo, a girl, was what our genetic counselor called “mosaic,” meaning it had both abnormal and normal cells.

Starting in the late 1990s, doctors testing fertilized eggs classified them as normal or abnormal, then added the classification “mosaic” in 2015. Mosaic embryos can be either low- or high-level, depending on the number of abnormal cells. Twenty percent of tested embryos are mosaic.

Ours was a low-level mosaic embryo, with a few cells having an extra 22nd chromosome. Scientists are still trying to understand mosaicism, but this meant our embryo could be normal and lead to a healthy baby; she could have genetic abnormalities that would lead to miscarriage; or she could be born with congenital heart defects, asymmetrical development (meaning one side of her body could look like it was melting while the opposite side looked normal) or other disabilities that would cause her to use a wheelchair for life. It was like rolling the dice, except for someone you’ve never met.

It turns out there are a lot of online communities for mosaic kids and their families, including one on Facebook dedicated specifically to mosaics with an extra 22nd chromosome. Some adults lived normal lives and only find they have mosaic +22 later in life. Some women who were pregnant with babies with mosaic +22 miscarried. Children — ranging from newborns to young adults — had varying developmental challenges.

What scared me most was that in girls, the extra 22nd chromosome could cause infertility. I felt selfish for wanting her so desperately that I would allow her into the world without this same opportunity.

We had to make a fast choice: do a third cycle of I.V.F., hoping to get a normal embryo, or risk transferring the mosaic. Should we first try the mosaic embryo or risk having more nonviable embryos to agonize over? Because of the risks to the fetus and the developmental challenges our baby might face, the genetic counselor advised us to not transfer.

I had always hoped my future children wouldn’t be short like me. My husband, who sprouts freckles in the sun, hoped they would inherit my darker skin. Otherwise, we had no lofty dreams of them going to Harvard or making any “world’s most beautiful baby” list. We picked a dog that was the runt of the litter, with a lopsided face, because we thought she was modern art. But that’s a lot different from bringing a child into the world knowing it had a risk of living a difficult life.

It was a lot to take in. I wasn’t scared that my life would be curtailed if I brought up a child with special needs — I was ready to dedicate myself to a child. But I worried that my wanting a child was blinding me to some of my potential shortcomings. Was I capable of giving up everything to concentrate on this person who would need me in ways I couldn’t even fathom yet? I was terrified that I couldn’t handle having a child with special needs and would take it out on her.

I was also a little embarrassed that I cared so much about having a “perfect” baby that fit the standard 46-chromosome human body. Who was I to make this life and death decision for another human?

But it turns out that I didn’t know as much as I thought I did. Because genetic tests of I.V.F. embryos are far from perfect.

“Labs only test five cells from around 150 that make up the fertilized egg,” said Dr. Hugh Taylor, chairman of the Department of Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine. “We’re fooling ourselves if we think we have full information on an embryo based on those few cells.”

A recently published study of 1,000 mosaic embryos found those that progressed into a late-term pregnancy and full term birth had similar odds of being born without any discernible genetic differences to a normal embryo. But there were no guarantees.

I didn’t want to try another I.V.F. cycle. In late February 2020, we decided to transfer the embryo into my uterus — just in time for New York City to shut down during the pandemic.

Five months later, I got a call from a physician who was filling in for my doctor; she canceled my appointment, claiming she was uncomfortable transferring a mosaic embryo. I was livid and overcome with grief.

“The larger question that emerges with embryo testing is who gets to take on the risk of possibly bringing a child with potential disabilities into the world,” Dr. Taylor said. “The decision should not be left to physicians. Patients should be given the freedom to decide, and properly counseled in cases where there are abnormalities that will inevitably lead to death.”

Parents I had met online described wheeling or driving their frozen abnormal and mosaic embryos in unwieldy metal tanks to other clinics when their physicians refused to transfer. Fortunately, my regular doctor came back and scheduled a new appointment for the following month.

My husband and I got lucky. Our beautiful, imperfect embryo attached to the uterine wall, mesmerizing us with her wild beating heart at biweekly ultrasounds. As each week brought on fresh worries — that I could miscarry, that the baby might have other abnormalities not caught at embryo testing — I found comfort in Dr. Taylor’s words: “Mosaicism is more common than we think. Many of us are mosaic without knowing it.”

At three months, my doctor recommended a blood test that checked the baby’s DNA fragments in my blood to see if she was at risk for genetic abnormalities. At this point, my husband and I had begun to notice families in the dog park whose children had genetic disabilities. We quietly found acceptance that we would add variety to the families in our community and decided that we wouldn’t terminate the baby — no matter the result.

They came back as normal. But like embryo testing, the blood test couldn’t diagnose a fetus’s genetic condition with certainty. Our doctor offered a more accurate amniocentesis test, but we had already made our decision. I decided to leave it there.

Now, during ultrasounds, our daughter hides her face behind her hands or presses hard against the placenta, as if asking us to let her grow in privacy. The last time I glimpsed her full profile, at five months gestation, her nose, long and sharp, was prominent and unmistakable. I wondered if it was one of the characteristics of the extra 22nd chromosome or if she’d simply inherited my husband’s nose. As my due date draws nearer, her genetic profile is less of a concern. I’m thrilled we’ve made it this far.


Jacquelynn Kerubo is a writer and public health communicator.

After Genetic Testing, I Took a Chance on an ‘Imperfect’ Pregnancy

‘It was like rolling the dice, except for someone you’ve never met.’

My husband and I were sitting in an Upper East Side office with deep-toned velvet couches and fluffy throw pillows, surrounded by photos of smiling babies, as the fertility doctor gave his spiel. He told us that after age 35, a woman’s chances of getting pregnant drop. Older women produce few normal embryos even with fertility treatment. But we’d have a healthy baby in our arms within a year — if we tested the embryos.

By testing the chromosomes in my embryos, he said, we could weed out the abnormal embryos that may lead to miscarriage or a child with disabilities and only use viable ones.

I’ve always been a late bloomer — I met my husband at 37 and married at 39. I was in good health but pushing 40, with diminishing egg count and quality. After six months of trying to conceive on our own, we wanted all the help we could get. My husband and I jumped at the embryo testing suggestion.

After two long rounds of in vitro fertilization, we had five embryos, but the genetic testing deemed four of them “abnormal,” meaning they contained extra or missing chromosomes. Our fifth embryo, a girl, was what our genetic counselor called “mosaic,” meaning it had both abnormal and normal cells.

Starting in the late 1990s, doctors testing fertilized eggs classified them as normal or abnormal, then added the classification “mosaic” in 2015. Mosaic embryos can be either low- or high-level, depending on the number of abnormal cells. Twenty percent of tested embryos are mosaic.

Ours was a low-level mosaic embryo, with a few cells having an extra 22nd chromosome. Scientists are still trying to understand mosaicism, but this meant our embryo could be normal and lead to a healthy baby; she could have genetic abnormalities that would lead to miscarriage; or she could be born with congenital heart defects, asymmetrical development (meaning one side of her body could look like it was melting while the opposite side looked normal) or other disabilities that would cause her to use a wheelchair for life. It was like rolling the dice, except for someone you’ve never met.

It turns out there are a lot of online communities for mosaic kids and their families, including one on Facebook dedicated specifically to mosaics with an extra 22nd chromosome. Some adults lived normal lives and only find they have mosaic +22 later in life. Some women who were pregnant with babies with mosaic +22 miscarried. Children — ranging from newborns to young adults — had varying developmental challenges.

What scared me most was that in girls, the extra 22nd chromosome could cause infertility. I felt selfish for wanting her so desperately that I would allow her into the world without this same opportunity.

We had to make a fast choice: do a third cycle of I.V.F., hoping to get a normal embryo, or risk transferring the mosaic. Should we first try the mosaic embryo or risk having more nonviable embryos to agonize over? Because of the risks to the fetus and the developmental challenges our baby might face, the genetic counselor advised us to not transfer.

I had always hoped my future children wouldn’t be short like me. My husband, who sprouts freckles in the sun, hoped they would inherit my darker skin. Otherwise, we had no lofty dreams of them going to Harvard or making any “world’s most beautiful baby” list. We picked a dog that was the runt of the litter, with a lopsided face, because we thought she was modern art. But that’s a lot different from bringing a child into the world knowing it had a risk of living a difficult life.

It was a lot to take in. I wasn’t scared that my life would be curtailed if I brought up a child with special needs — I was ready to dedicate myself to a child. But I worried that my wanting a child was blinding me to some of my potential shortcomings. Was I capable of giving up everything to concentrate on this person who would need me in ways I couldn’t even fathom yet? I was terrified that I couldn’t handle having a child with special needs and would take it out on her.

I was also a little embarrassed that I cared so much about having a “perfect” baby that fit the standard 46-chromosome human body. Who was I to make this life and death decision for another human?

But it turns out that I didn’t know as much as I thought I did. Because genetic tests of I.V.F. embryos are far from perfect.

“Labs only test five cells from around 150 that make up the fertilized egg,” said Dr. Hugh Taylor, chairman of the Department of Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine. “We’re fooling ourselves if we think we have full information on an embryo based on those few cells.”

A recently published study of 1,000 mosaic embryos found those that progressed into a late-term pregnancy and full term birth had similar odds of being born without any discernible genetic differences to a normal embryo. But there were no guarantees.

I didn’t want to try another I.V.F. cycle. In late February 2020, we decided to transfer the embryo into my uterus — just in time for New York City to shut down during the pandemic.

Five months later, I got a call from a physician who was filling in for my doctor; she canceled my appointment, claiming she was uncomfortable transferring a mosaic embryo. I was livid and overcome with grief.

“The larger question that emerges with embryo testing is who gets to take on the risk of possibly bringing a child with potential disabilities into the world,” Dr. Taylor said. “The decision should not be left to physicians. Patients should be given the freedom to decide, and properly counseled in cases where there are abnormalities that will inevitably lead to death.”

Parents I had met online described wheeling or driving their frozen abnormal and mosaic embryos in unwieldy metal tanks to other clinics when their physicians refused to transfer. Fortunately, my regular doctor came back and scheduled a new appointment for the following month.

My husband and I got lucky. Our beautiful, imperfect embryo attached to the uterine wall, mesmerizing us with her wild beating heart at biweekly ultrasounds. As each week brought on fresh worries — that I could miscarry, that the baby might have other abnormalities not caught at embryo testing — I found comfort in Dr. Taylor’s words: “Mosaicism is more common than we think. Many of us are mosaic without knowing it.”

At three months, my doctor recommended a blood test that checked the baby’s DNA fragments in my blood to see if she was at risk for genetic abnormalities. At this point, my husband and I had begun to notice families in the dog park whose children had genetic disabilities. We quietly found acceptance that we would add variety to the families in our community and decided that we wouldn’t terminate the baby — no matter the result.

They came back as normal. But like embryo testing, the blood test couldn’t diagnose a fetus’s genetic condition with certainty. Our doctor offered a more accurate amniocentesis test, but we had already made our decision. I decided to leave it there.

Now, during ultrasounds, our daughter hides her face behind her hands or presses hard against the placenta, as if asking us to let her grow in privacy. The last time I glimpsed her full profile, at five months gestation, her nose, long and sharp, was prominent and unmistakable. I wondered if it was one of the characteristics of the extra 22nd chromosome or if she’d simply inherited my husband’s nose. As my due date draws nearer, her genetic profile is less of a concern. I’m thrilled we’ve made it this far.


Jacquelynn Kerubo is a writer and public health communicator.

Coronavirus Reinfections Are Rare, Danish Researchers Report

People over 65 are more likely to experience a second bout with the virus, according to a large study of medical records.

The vast majority of people who recover from Covid-19 remain shielded from the virus for at least six months, researchers reported on Wednesday in a large study from Denmark.

Prior infection with the coronavirus reduced the chances of a second bout by about 80 percent in people under 65, but only by about half in those older than 65. But those results, published in the journal Lancet, were tempered by many caveats.

The number of infected older people in the study was small. The researchers did not have any information beyond the test results, so it’s possible that only people who were mildly ill the first time became infected again and that the second infections were largely symptom-free.

Scientists have said that reinfections are likely to be asymptomatic or mild because the immune system will suppress the virus before it can do much damage. The researchers also did not assess the possibility of reinfection with newer variants of the virus.

Still, the study suggests that immunity to a natural infection is unpredictable and uneven, and it underscores the importance of vaccinating everyone — especially older people, experts said.

“You can certainly not rely on a past infection as protecting you from being ill again, and possibly quite ill if you are in the elderly segment,” said Steen Ethelberg, an epidemiologist at Statens Serum Institut, Denmark’s public health agency.

Because people over 65 are at highest risk of severe disease and death, he said, “they are the ones we are most eager to protect.”

Rigorous estimates of second infections have generally been rare because many people worldwide did not initially have access to testing, and laboratories require genetic sequences from both rounds of testing to confirm a reinfection.

But the findings are consistent with those from experiments in a wide variety of settings: sailors on a fishing trawler in Seattle, Marine Corps recruits in South Carolina, health care workers in Britain and patients at clinics in the United States.

The new study’s design and size benefited from Denmark’s free and abundant testing for the coronavirus. Nearly 70 percent of the country’s population was tested for the virus in 2020.

The researchers looked at the results from 11,068 people who tested positive for the coronavirus during the first wave in Denmark between March and May 2020. During the second wave, from September to December, 72 of those people, or 0.65 percent, again tested positive, compared with 3.27 percent of people who became infected for the first time.

That translates to a 80 percent protection from the virus in those who had been infected before. The protection fell to 47 percent for those over 65. The team also analyzed test results from nearly 2.5 million people throughout the epidemic, some longer than seven months after the first infection, and found similar results.

“It was really nice to see that there was no difference in protection from reinfection over time,” said Marion Pepper, an immunologist at the University of Washington in Seattle.

She and other experts noted that while 80 percent might not seem superb, protection from symptomatic illness was likely to be higher. The analysis included anyone who was tested, regardless of symptoms.

“A lot of these will be asymptomatic infections, and a lot of these will likely be people who have a blip of virus,” noted Florian Krammer, an immunologist at the Icahn School of Medicine at Mount Sinai in New York. “Eighty percent risk reduction against asymptomatic infection is great.”

The findings indicate that people who have recovered from Covid-19 should get at least one dose of a coronavirus vaccine to boost the level of protection, Dr. Krammer added. Most people produce robust immune response to a natural infection, “but there’s a lot of variability,” he said. Following vaccination, “we don’t see variability — we see very high responses in basically everybody, with very few exceptions.”

Experts were less convinced by the results in people over 65, saying the findings would have been more robust if the analysis had included more people from that age group.

“I wish it had actually been broken down into specific decades over 65,” Dr. Pepper said. “It would be nice to know whether the majority of people who were getting reinfected were over 80.”

The immune system grows progressively weaker with age, and people over 80 typically mount weak responses to infection with a virus. The lower protection in older people seen in the study is consistent with those observations, said Akiko Iwasaki, an immunologist at Yale University.

“I think we kind of tend to forget how the vaccines have been pretty amazing in offering protection in this age group, because you can see that natural infection doesn’t confer the same kind of protection,” she said. “This really does emphasize the need to cover older people with the vaccine, even if they have had Covid first.”

Advanced Cancers Are Emerging, Doctors Warn, Citing Pandemic Drop in Screenings

People have skipped their cancer screenings and ignored possible symptoms as a result of the pandemic. In some cases, the delay has come at a great cost.

Yvette Lowery usually gets her annual mammogram around March. But last year, just as the pandemic was gaining a foothold and medical facilities were shutting down, the center where she goes canceled her appointment. No one could tell her when to reschedule.

“They just said keep calling back, keep calling back,” said Ms. Lowery, 59, who lives in Rock Hill, S.C.

In August, Ms. Lowery felt a lump under her arm but still couldn’t get an appointment until October.

Eventually, she received a diagnosis of Stage 2 breast cancer, started chemotherapy in November and had a double mastectomy this month.

“I’ve been seeing a lot of patients at an advanced stage,” said Dr. Kashyap B. Patel, one of Ms. Lowery’s doctors and the chief executive of Carolina Blood and Cancer Care Associates. If her cancer had been detected last May or June, it would have probably been caught before it had spread, Dr. Patel said.

Months of lockdowns and waves of surging Covid cases throughout last year shuttered clinics and testing labs, or reduced hours at other places, resulting in steep declines in the number of screenings, including for breast and colorectal cancers, experts have said.

Numerous studies showed that the number of patients screened or given a diagnosis of cancer fell during the early months of the pandemic. By mid-June, the rate of screenings for breast, colon and cervical cancers were still 29 percent to 36 percent lower than their prepandemic levels, according to an analysis of data by the Epic Health Research Network. Hundreds of thousands fewer screenings were performed last year than in 2019, according to the network data.

“We still haven’t caught up,” said Dr. Chris Mast, vice president of clinical informatics for Epic, which develops electronic health records for hospitals and clinics.

Another analysis of Medicare data suggested that as Covid cases spiked during certain periods in 2020, cancer screenings fell. The analysis — conducted by Avalere Health, a consulting firm, for Community Oncology Alliance, which represents independent cancer specialists — found that testing levels in November were about 25 percent lower than in 2019. The number of biopsies, used to diagnose cancer, decreased by about one-third.

While it is too early to assess the full impact of the delays in screenings, many cancer specialists say they are concerned that patients are coming in with more severe disease.

“There’s no question in practice that we are seeing patients with more advanced breast cancer and colorectal cancer,” said Dr. Lucio N. Gordan, the president of the Florida Cancer Specialists & Research Institute, one of the nation’s largest independent oncology groups. He is working on a study to see if, over all, these missed screenings resulted in more patients with later-stage cancers.

Yvette Lowery in Rock Hill, S.C. 
Yvette Lowery in Rock Hill, S.C. Travis Dove for The New York Times

And even though the numbers of mammograms and colonoscopies have rebounded in recent months, many people with cancer remain undiagnosed, doctors are reporting.

Some patients, like Ms. Lowery, could not easily get an appointment once clinics reopened because of pent-up demand. Others skipped regular testing or ignored worrisome symptoms because they were afraid of getting infected or after losing their jobs, they couldn’t afford the cost of a test.

“The fear of Covid was more tangible than the fear of missing a screen that detected cancer,” said Dr. Patrick I. Borgen, the chair of surgery at the Maimonides Medical Center in Brooklyn who also leads its breast center. His hospital treated such large numbers of coronavirus patients early on that “we’re now associated as the Covid hospital,” he said, and healthy people stayed away to avoid contagion.

Even patients at high risk because of their genetic makeup or because they previously had cancer have missed critical screenings. Dr. Ritu Salani, the director of gynecologic oncology at the UCLA Health Jonsson Comprehensive Cancer Center said one woman, who was at risk for colon cancer, had a negative test in 2019 but didn’t go for her usual screening last year because of the pandemic.

When she went to see her doctor, she had advanced cancer. “It’s just a devastating story,” Dr. Salani said. “Screening tests are really designed when patients aren’t feeling bad.”

Ryan Bellamy felt no hurry last spring to reschedule a canceled colonoscopy, even though the presence of blood in his stool had prompted him to look up symptoms. “I really didn’t want to go to the hospital,” Mr. Bellamy said. He decided it was unlikely he had cancer. “They’re not following up with me so I’m OK with Googling,” he told himself.

A resident of Palm Coast, Fla., Mr. Bellamy said that after his symptoms worsened, his wife insisted that he go for testing in December, and he had a colonoscopy in late January. With a new diagnosis of Stage 3 rectal cancer, Mr. Bellamy, 38, is undergoing radiation treatment and chemotherapy.

Colon screening remained significantly lower in 2020, declining about 15 percent from 2019 levels, according to the Epic network data, although overall screenings were down 6 percent. The analysis looked at screenings for more than 600 hospitals in 41 states.

Eric Prieto holding a picture of his family. His wife, Sandy Prieto, died after receiving a diagnosis of Stage 4 pancreatic cancer.Salgu Wissmath for The New York Times

Lung cancer patients have also delayed seeking appropriate care, said Dr. Michael J. Liptay, chairman of cardiovascular and thoracic surgery at Rush University Medical Center in Chicago. One patient had imaging that showed a spot on his lung, and he was supposed to follow up, just as the pandemic hit. “Additional work-up and care was deferred,” Dr. Liptay said. By the time the patient was fully evaluated, the cancer had increased in size. “It wasn’t a good thing to wait 10 months,” Dr. Liptay said, although he was uncertain whether earlier treatment would have changed the patient’s prognosis.

Just as previous economic recessions led people to forgo medical care, the downturn in the economy during the pandemic has also discouraged many people from seeking help or treatment.

“We know cancers are out there,” said Dr. Barbara L. McAneny, the chief executive of New Mexico Oncology Hematology Consultants. Many of her patients are staying away, even if they have insurance, because they cannot afford the deductibles or co-payments. “We’re seeing that, particularly with our poorer folks who are living on the edge anyway, living paycheck to paycheck,” she said.

Some patients ignored their symptoms as long as they could. Last March, Sandy Prieto, a school librarian who lived in Fowler, Calif., had stomach pain. But she refused to go to the doctor because she didn’t want to get Covid. After having a telehealth visit with her primary care doctor, she tried over-the-counter medications, but they didn’t help with the pain and nausea. She continued to decline.

“It got to the point where we didn’t have a choice,” said her husband, Eric, who had repeatedly urged her to go to the doctor. Jaundiced and in severe discomfort, she went to the emergency room at the end of May and was given a diagnosis of Stage 4 pancreatic cancer. She died in September.

“If it wasn’t for Covid and we could have gotten her some place earlier, she would still be with us today,” said her sister, Carolann Meme, who had tried to persuade Ms. Prieto to go to an academic medical center where she might have gotten into a clinical trial.

Mr. Prieto, left, with his son, Ethan, outside their home in Fowler, Calif. He repeatedly urged his wife to seek treatment.Salgu Wissmath for The New York Times

When patients like Ms. Prieto are not seen in person but treated virtually, doctors may easily miss important symptoms or recommend medication rather than tell them to come in, said Dr. Ravi D. Rao, the oncologist who treated Ms. Prieto. Patients may downplay how sick they feel or neglect to mention the pain in their hip, he said.

“In my mind, telemedicine and cancer don’t travel together,” Dr. Rao said. While he also made use of telemedicine during the height of the pandemic, he says he worked to keep his offices open.

Other doctors defended the use of virtual visits as a critical tool when office visits were too hazardous for most patients and staff. “We were grateful to have a robust telemedicine effort when people simply couldn’t come into the center,” said Dr. Borgen of Maimonides. But he acknowledged that patients were frequently reluctant to discuss their symptoms during a telehealth session, especially a mother whose young children could be listening to what they were saying. “It’s not private,” he noted.

Some health networks say they took aggressive steps to try to counteract the effects of the pandemic. During the initial stay-at-home order last year, Kaiser Permanente, the large California-based managed care outfit, spotted a declining number of breast cancer screenings and diagnoses in the northern part of the state. “Doctors immediately got together” to begin contacting patients, said Dr. Tatjana Kolevska, medical director for the Kaiser Permanente National Cancer Excellence Program.

Kaiser also relies on its electronic health records to make appointments for women who are overdue for their mammograms when they book an appointment with their primary care doctor or even want to get a prescription for new glasses.

While Dr. Kolevska says she is waiting to see data for the system as a whole, she has been encouraged by the number of patients in her practice who are now up to date with their mammograms.

“All of those things put in place have helped tremendously,” she said.

Lung Cancer Scans Are Recommended for People 50 and Older With Shorter Smoking Histories

Yearly Lung Cancer Scans Are Advised for People 50 and Over With Shorter Smoking Histories

New advice from an influential panel will make more women and African-Americans eligible for CT scans, but some who need them most may not be able to afford them.

A computed tomography scan of the lungs of a healthy adult man. The panel recommended low-dose CT scans, so-called because they involve a relatively small amount of radiation, and cost about $300.
A computed tomography scan of the lungs of a healthy adult man. The panel recommended low-dose CT scans, so-called because they involve a relatively small amount of radiation, and cost about $300.Credit…Alamy Stock Photo

  • March 9, 2021, 11:00 a.m. ET

New guidelines from medical experts will nearly double the number of people in the United States who are advised to have yearly CT scans to screen for lung cancer, and will include many more African-Americans and women than in the past.

The disease is the leading cause of U.S. cancer deaths, and the goal of the expanded screening is to find it early enough to cure it in more people at high risk because of smoking. In those individuals, annual CT scans can reduce the risk of death from the cancer by 20 to 25 percent, large studies have found.

The new recommendations, by the U.S. Preventive Services Task Force, include people ages 50 to 80 who have smoked at least a pack a day for 20 years or more, and who still smoke or have quit within the past 15 years.

The advice, published on Tuesday in the medical journal JAMA, differs in two major ways from the task force’s previous guidelines, issued in 2013: It lowers the age when screening should start, to 50 from 55, and it reduces the smoking history to 20 years, from 30.

Those changes will add more women and African-Americans to the pool eligible for screening, because they tend to smoke less heavily than the white male study participants on whom earlier guidelines were based. Women and Black Americans also tend to develop lung cancer earlier and from less tobacco exposure than do white men, experts said.

Why the risk appears to differ by race and gender is not known.

“Some studies have alluded to some hormonal influences in women,” Dr. Mara Antonoff, a lung surgeon at the M.D. Anderson Cancer Center in Houston, said in an interview. “In terms of racial differences, we don’t have an answer. We have population-based data to show they have a tendency to develop lung cancer younger and with less exposure to tobacco, but we don’t have a mechanism.”

Under the new criteria, 14.5 million people in the United States will qualify for the screening, an increase of 6.4 million.

The task force includes 16 physicians, scientists and public health experts who periodically evaluate screening tests and preventive treatments. Members are appointed by the director of the federal Agency for Healthcare Research and Quality, but the group is independent and its recommendations often help shape U.S. medical practice.

The use of chest X-rays to detect lung cancer was largely abandoned decades ago because they could not find the disease early enough to be useful.

The CT scans, called low-dose CT — because they involve a relatively small amount of radiation — cost about $300. Patients are advised to stop the screening once they have not smoked for 15 years, or if they develop health problems that would substantially shorten their life expectancy or make them unable to have lung surgery if needed.

Patients have not flocked to clinics for this screening. Researchers estimate that only 6 to 18 percent of those who qualify and could be helped by the screening have taken advantage of it. Some cannot afford it.

“Part of the low uptake is simply lack of access to care,” said Dr. Robert Smith, a screening expert at the American Cancer Society. “Smoking in general is increasingly concentrated in lower-income populations.”

The Affordable Care Act does require that insurers cover any screening broadly recommended by the task force, with no out-of-pocket costs.

Bettye Givens, right, of south Kansas City, reviewing lung scans with her doctor in 2017. She received a low-dose CT scan that detected her lung cancer at its earliest stage and was successfully treated.
Bettye Givens, right, of south Kansas City, reviewing lung scans with her doctor in 2017. She received a low-dose CT scan that detected her lung cancer at its earliest stage and was successfully treated.Credit…Andy Marso/Kansas City Star/TNS/Alamy Live News

But researchers have found that half the population eligible for lung-cancer screening had either no insurance, or Medicaid, Dr. Smith said. Not all Medicaid plans have covered the screening, according to an editorial in JAMA.

“There could be a 15-year period when you might quality for screening and not have any insurance,” Dr. Smith said.

He and other researchers also said that patients may be missing out on lung-cancer screening because they just don’t know about it. It has not received as much attention as other cancer screenings, like mammograms, colonoscopies and Pap tests. Some doctors may not encourage it as strongly, and especially with former smokers, may not take the time to calculate a patient’s smoking history to see if it matches the guidelines.

The changes in the criteria for smoking history and screening age were based on new data from multiple studies, Dr. Alex H. Krist, the task force chairman and a professor of family medicine and population health at Virginia Commonwealth University, said in an interview.

“Lung cancer is the No. 1 cancer killer in America,” Dr. Krist said, adding that with the new data, “we have even more confidence that screening does save lives.”

Like other kinds of screenings affected by the pandemic, those for lung cancer remain below 2019 levels, according to an analysis of Medicare data by Avalere Health, a consulting firm, conducted for Community Oncology Alliance, which represents independent cancer specialists.

While the number of screenings had started to rebound in the summer, the fresh spike in Covid cases later in the year caused them to fall again. In November, screenings were down by 30 percent, compared to 2019, and the number of lung biopsies had also dropped, indicating cases were not being diagnosed.

Using its own grading system, the task force gave its recommendation a B, saying there was “moderate certainty” that annual screening was of “moderate net benefit.”

That may not sound like a ringing endorsement, given that a grade of A means “high certainty that the net benefit is substantial.” But anything with an A or B grade should be offered to patients, according to task force rules.

“There is building evidence that a pretty simple, five-minute, low-dose, low radiation scan can really save a lot of people’s lives,” said Dr. Bernard J. Park, a lung surgeon and the clinical director of the lung-screening service at Memorial Sloan Kettering Cancer Center in New York. About 75 to 85 percent of the cancers found with this screening are Stage 1, and curable with just surgery or radiation, he estimated.

Dr. Park said that many people who signed up for the screening had quit smoking or were trying to stop, but that a few regarded clear scans as a sign that they could keep smoking.

Dr. Smith said that the American Cancer Society was due to revise its own guidelines for lung-cancer screening, and that its advice would probably be similar to that of the task force.

In 2013, the American Academy of Family Physicians declined to recommend for or against CT screening for lung cancer, saying there was insufficient evidence. But the president, Dr. Ada Stewart, said in an emailed statement on Monday that the academy would review the new task force evidence and decide whether to update its own recommendation to its members.

There were 228,820 new cases of lung cancer in the United States in 2020, and 135,720 people died from it, according to the National Cancer Institute. About 90 percent of cases occur in people who smoke, and current smokers’ risk of developing the disease is about 20 times that of nonsmokers.

Only about 20.5 percent of patients survive five years after the diagnosis. Most cases are diagnosed late, after the cancer has begun to spread. But if it can be found and treated early, cure is possible, doctors say.

CT screening has risks, and doctors say those must be explained to patients, who may decide to decline the testing. The scans detect tiny nodules in the lungs that may be early cancers — or maybe not. A suspicious-looking spot could be just a minor infection, inflammation or a benign growth, Dr. Park said.

Often, the nodules can just be monitored with repeat scans, but it can be nerve-racking for patients to spend months waiting for the next test, knowing there is something in their lung that might be malignant.

False positive rates, when something harmless is mistaken for cancer, have ranged from 3.9 to 25 percent and higher in studies, but tend to decrease over time, as the patient has more annual scans.

A major concern about false positives is that they can lead to invasive procedures like lung biopsies. One large study found that invasive procedures were performed needlessly in 1.7 percent of the patients who were screened. The task force report said that standards created by radiology societies for evaluating the scans could help to prevent some unnecessary procedures spurred by false positives.

Another possible risk from screening is the chance that the cumulative radiation exposure could cause cancer. But the dose is low, and the risk is thought to be small, especially when compared with the risk of lung cancer caused by smoking.

In theory, screening could also lead to unneeded invasive tests and treatment for a cancer that would not have progressed or harmed the patient. How often that might occur is not known, but it is considered rare.

Reed Abelson contributed to this article.

At-Home Covid Testing Is Here

At-Home Covid Testing Is Here

But does it work?

Credit…Rose Wong

  • Feb. 26, 2021, 12:44 p.m. ET

In case you missed it: You can now get tested for the coronavirus in the comfort of your own home.

This is great news, especially for people who don’t have access to a testing site. Currently, these portable tests come in two flavors. The first is test-by-mail kits, which allow patients to swab their noses at home and mail them to a laboratory for a result in a day or two. The other types are called at-home tests, which give an answer on the spot.

Currently, the United States Food and Drug Administration has authorized dozens of test-by-mail kits, and three at-home tests.

These tests are not nearly as accurate as those taken in a clinic, but experts say coronavirus tests that can be done at home play an important role as the country continues to reopen. “They get actionable information in people’s hands quickly,” said Jennifer Bacci, an assistant professor at the University of Washington School of Pharmacy.

Of course, no coronavirus diagnostic test is 100 percent accurate. Even the gold-standard nasopharyngeal swab, given at many clinics, can return a negative result even though you might be carrying the coronavirus. And these tests only inform you about a single point in time. But even if home tests may be less accurate, they can quickly alert people if they test positive.

Certainly the market for home test kits will likely grow, said Gigi Gronvall, a public health expert at Johns Hopkins University. But with more options, consumers will need to learn what test is best for them.

Here are some key questions to consider when deciding on an at-home testing kit.

What are the trade-offs between mail-in kits and fully at-home tests?

Test-by-mail kits require users to purchase a kit, take a sample at home and ship the swab back to a lab. These kits take more processing time and use a method called polymerase chain reaction, or P.C.R., to detect coronavirus.

P.C.R. works by identifying and magnifying specific gene sequences. “It can take a very small signal and amplify it,” to detect smaller amounts of the virus, said Dr. Gronvall. These tests are highly sensitive, picking up positive cases nearly all the time (accuracy varies by lab, and false negatives can be as high as 20 percent). “A negative P.C.R. isn’t perfect, but it gives a high degree of assurance,” said Dr. Ashish Jha, dean of the Brown University School of Public Health.

Fully at-home tests, such as those made by Ellume and Abbott, require users to swab their noses and drop the swabs in a liquid. The tests provide an answer in as little as 15 minutes for the Abbott test and 20 minutes for Ellume.

These tests look for antigens — parts of microbes that cause an immune response. Unlike P.C.R., antigen tests do not amplify signals, which makes them faster but less accurate. These rapid antigen tests, Dr. Gronvall said, are good for measuring how contagious you are. “If you test positive on that, you really need to isolate,” she said, and get a clinical swab done to confirm the results.

False negatives, however, are much more common with antigen tests, meaning infected people might think they are virus free, especially if they are not having symptoms.

“The sensitivity of these tests tend to be pretty bad,” said Dr. Yvonne Maldonado, an infectious disease specialist at Stanford University School of Medicine. If users have symptoms, the BinaxNOW antigen test has a 64 percent chance of correctly spotting the virus (and about half that in those without symptoms). Accuracy for some antigen tests in asymptomatic individuals can be less than 50 percent — worse than flipping a coin, she said.

Remember, any test’s ability to detect coronavirus depends on how much virus is in the location of your body where you are taking a sample. Tests taken early, say, hours after a potential virus exposure, have a higher chance of being a false negative.

What home test should you use?

If you’re asymptomatic, you may have a smaller amount of virus in your body. In this case, experts said that your best bet for an accurate test is to use a test-by-mail kit because P.C.R. will be able to amplify lower levels of virus.

If you have symptoms, either a P.C.R.-based test or an antigen test will likely be able to confirm you have it. When choosing an antigen test, Dr. Jha said to look for whichever option at your disposal has the highest sensitivity, which refers to a test’s ability to detect the virus. Look for a sensitivity rating from 95 to 99 percent, he said.

Turnaround time is also important. Antigen tests are less accurate but offer an answer much faster without having to mail a sample. Results of either test should always be confirmed by a clinical test, said Dr. Maldonado.

Costs, too, may play a factor. Test-by-mail kits can cost $100 or more and may not be reimbursed by insurance companies. “Many patients have encountered unanticipated bills or red tape when seeking reimbursement for mail-in coronavirus testing, even though insurance companies are obligated to do so,” said Dr. Marisa Cruz, head of clinical affairs at Everlywell, a company that makes at-home health tests, including one for coronavirus.

Antigen tests, on the other hand, are a fraction of the cost, currently ranging from $25 to $50.

What should you check for on the box?

Make sure the home test or collection kit you’re looking to buy has an emergency use authorization from the F.D.A. (it will be printed on the box) and that the company works with certified lab partners. Also look for tests that offer a telemedicine consult, advised Dr. Cruz, so you can discuss your diagnosis and next steps.

How should I interpret a result from an at-home coronavirus test?

Following the test kit instructions is key to getting a reliable result. “A specimen that is not collected correctly may lead to false negative test results,” said Dr. Cruz. Imperfect swabbing technique, or swabbing only one nostril, may increase the risk of less accurate results. And samples for test-by-mail kits should be shipped the same day they are collected; the less time in transit, the better. Samples sent on weekends or holidays may be delayed, though some use FedEx and overnight shipping.

If you test positive on either a mail-in P.C.R. or at-home antigen test, you are likely to be infected and presumed contagious, said Dr. Bacci, so isolate from others and continue to monitor your symptoms. Repeat testing can help track the disease course, if, say, someone goes from being asymptomatic to displaying symptoms.

Negative results are more likely to be wrong than positive ones. “A negative result does not necessarily mean you do not have Covid, which is the same interpretation for either an at-home test, a mail-in test or one offered in a doctor’s office,” said Dr. Cruz. Continue to wear masks, socially distance and practice good hygiene, especially if you have symptoms or known contacts with others with Covid.

When would a test be inappropriate to use?

Dr. Gronvall is concerned that some people are using at-home tests after they’ve been vaccinated to make sure that the vaccine has worked. But neither the P.C.R. or antigen-based tests will be able to discern whether the vaccines have built up immunity in your body.

That’s because the vaccines encode for snippets of the virus and not the entire sequence. The P.C.R. and antigen tests search for a different portion of the virus from what’s included in the vaccines.

“These tests are not going to tell people if the vaccine is effective,” she said.

What does the future of at-home testing look like?

Beyond saliva and nasal swabs, some scientists are looking to develop devices that look like breathalyzers to detect chemicals in an individual’s breath that correspond to coronavirus infection. “We’re looking for the body’s response to infection and disease,” said Pelagia-Iren Gouma, a materials engineer at The Ohio State University.

Dr. Gouma and her colleagues are testing a small breathalyzer they have developed that can be used for up to one year and would cost perhaps a few dollars per device. Users would get an answer in 15 seconds, and the test appears to be accurate 96 percent of the time and can be reused, Dr. Gouma said. The device was submitted to the F.D.A. and has been awaiting emergency use authorization since September.

Experts hope that as the market for at-home testing expands, the options will grow and become cheaper. The cheaper the tests are, the more likely the government will subsidize them and consumers will buy them for routine testing. And the more testing, the better. As the world slowly reopens, home-based tests will help people make better decisions.


Wudan Yan is a journalist based in Seattle, Wash., writing about science and society.

How Meaningful Is Prediabetes for Older Adults?

the new old age

How Meaningful Is Prediabetes for Older Adults?

A new study indicates that the condition might be less of a worry than once believed.

Susan Glickman Weinberg, of Encino, Calif., was told a few years ago during routine tests that she was prediabetic, a diagnosis that puzzled her. “I felt like Patient Zero,” she said. “There were a lot of unknowns.”
Susan Glickman Weinberg, of Encino, Calif., was told a few years ago during routine tests that she was prediabetic, a diagnosis that puzzled her. “I felt like Patient Zero,” she said. “There were a lot of unknowns.”Credit…Jenna Schoenefeld for The New York Times

  • Feb. 23, 2021, 2:30 a.m. ET

A few years ago, routine lab tests showed that Susan Glickman Weinberg, then a 65-year-old clinical social worker in Los Angeles, had a hemoglobin A1C reading of 5.8 percent, barely above normal.

“This is considered prediabetes,” her internist told her. A1C measures how much sugar has been circulating in the bloodstream over time. If her results reached 6 percent — still below the number that defines diabetes, which is 6.5 — her doctor said he would recommend the widely prescribed drug metformin.

“The thought that maybe I’d get diabetes was very upsetting,” recalled Ms. Weinberg, who as a child had heard relatives talking about it as “this mysterious terrible thing.”

She was already taking two blood pressure medications, a statin for cholesterol and an osteoporosis drug. Did she really need another prescription? She worried, too, about reports at the time of tainted imported drugs. She wasn’t even sure what prediabetes meant, or how quickly it might become diabetes.

“I felt like Patient Zero,” she said. “There were a lot of unknowns.”

Now, there are fewer unknowns. A longitudinal study of older adults, published online this month in the journal JAMA Internal Medicine, provides some answers about the very common in-between condition known as prediabetes.

The researchers found that over several years, older people who were supposedly prediabetic were far more likely to have their blood sugar levels return to normal than to progress to diabetes. And they were no more likely to die during the follow-up period than their peers with normal blood sugar.

“In most older adults, prediabetes probably shouldn’t be a priority,” said Elizabeth Selvin, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health in Baltimore and the senior author on the study.

Prediabetes, a condition rarely discussed as recently as 15 years ago, refers to a blood sugar level that is higher than normal but that has not crossed the threshold into diabetes. It is commonly defined by a hemoglobin A1C reading of 5.7 to 6.4 percent or a fasting glucose level of 100 to 125 mg/dL; in midlife, it can portend serious health problems.

A diagnosis of prediabetes means that you are more likely to develop diabetes, and “that leads to downstream illness,” said Dr. Kenneth Lam, a geriatrician at the University of California, San Francisco, and an author of an editorial accompanying the study. “It damages your kidneys, your eyes and your nerves. It causes heart attack and stroke,” he said.

But for an older adult just edging into higher blood sugar levels, it’s a different story. Those fearful consequences take years to develop, and many people in their 70s and 80s will not live long enough to encounter them.

That fact has generated years of debate. Should older people with slightly above-normal blood sugar readings — a frequent occurrence since the pancreas produces less insulin in later life — be taking action, as the American Diabetes Association has urged?

Or does labeling people prediabetic merely “medicalize” a normal part of aging, creating needless anxiety for those already coping with multiple health problems?

Dr. Selvin and her colleagues analyzed the findings of an ongoing national study of cardiovascular risk that began in the 1980s. When 3,412 of the participants showed up for their physicals and lab tests between 2011 and 2013, they had reached ages 71 to 90 and did not have diabetes.

Prediabetes, however, was rampant. Almost three-quarters qualified as prediabetic, based on either their A1C or fasting blood glucose levels.

These findings mirrored a 2016 study pointing out that a popular online risk test created by the Centers for Disease Control and Prevention and the American Diabetes Association, called doihaveprediabetes.org, would deem nearly everyone over 60 as prediabetic.

In 2010, a C.D.C. review reported that 9 to 25 percent of those with an A1C of 5.5 to 6 percent will develop diabetes over five years; so will 25 to 50 percent of those with A1C readings of 6 to 6.5. But those estimates were based on a middle-aged population.

When Dr. Selvin and her team looked at what had actually happened to their older prediabetic cohort five to six years later, only 8 or 9 percent had developed diabetes, depending on the definition used.

A much larger group — 13 percent of those whose A1C level was elevated and 44 percent of those with prediabetic fasting blood glucose — actually saw their readings revert to normal blood sugar levels. (A Swedish study found similar results.)

Sixteen to 19 percent had died, about the same proportion as those without prediabetes.

“We’re not seeing much risk in these individuals,” Dr. Selvin said. “Older adults can have complex health issues. Those that impair quality of life should be the focus, not mildly elevated blood glucose.”

Carol Jacobi, a friend of Ms. Weinberg’s, received a similar diagnosis at around the same time, but did nothing much to reduce her blood sugar.
Carol Jacobi, a friend of Ms. Weinberg’s, received a similar diagnosis at around the same time, but did nothing much to reduce her blood sugar.Credit…Jenna Schoenefeld for The New York Times

Dr. Saeid Shahraz, a health researcher at Tufts Medical Center in Boston and lead author of the 2016 study, praised the new research. “The data is really strong,” he said. “The American Diabetes Association should do something about this.”

It may, said Dr. Robert Gabbay, the A.D.A.’s chief scientific and medical officer. The organization currently recommends “at least annual monitoring” for people with prediabetes, a referral to the lifestyle modification programs shown to decrease health risks and perhaps metformin for those who are obese and under 60.

Now the association’s Professional Practice Committee will review the study, and “it could lead to some adjustments in the way we think about things,” Dr. Gabbay said. Among older people considered prediabetic, “their risk may be smaller than we thought,” he added.

Defenders of the emphasis on treating prediabetes, which is said to afflict one-third of the United States population, point out that first-line treatment involves learning healthy behaviors that more Americans should adopt anyway: weight loss, smoking cessation, exercise and healthy eating.

“I’ve had a number of patients diagnosed with prediabetes, and it’s what motivates them to change,” Dr. Gabbay said. “They know what they should be doing, but they need something to kick them into gear.”

Geriatricians tend to disagree. “It’s unprofessional to mislead people, to motivate them by fear of something that’s not actually true,” Dr. Lam said. “We’re all tired of having things to be afraid of.”

He and Dr. Sei Lee, a coauthor of the editorial accompanying the new study and a fellow geriatrician at the University of California, San Francisco, argue for a case-by-case approach in older adults — especially if a diagnosis of prediabetes will cause their children to berate them over every cookie.

For a patient who is frail and vulnerable, “you’re likely dealing with a host of other problems,” Dr. Lam said. “Don’t worry about this number.”

A very healthy 75-year-old who could live 20 more years faces a more nuanced decision. She may never progress to diabetes; she may also already follow the recommended lifestyle modifications.

Ms. Weinberg, now 69, sought help from a nutritionist, changed her diet to emphasize complex carbohydrates and protein, and began walking more and climbing stairs instead of taking elevators. She shed 10 pounds she didn’t need to lose. Over 18 months, her barely elevated A1C reading fell to 5.6.

Her friend Carol Jacobi, 71, who also lives in Los Angeles, got a similar warning at about the same time. Her A1C was 5.7, the lowest number defined as prediabetic, but her internist immediately prescribed metformin.

Ms. Jacobi, a retired fund-raiser with no family history of diabetes, felt unconcerned. She figured she could lose a little weight, but she had normal blood pressure and an active life that included lots of walking and yoga. After trying the drug for a few months, she stopped.

Now, neither woman has prediabetes. Although Ms. Jacobi did nothing much to reduce her blood sugar, and has gained a few pounds during the pandemic, her A1C has fallen to normal levels, too.

C.D.C. Announces $200 Million ‘Down Payment’ to Track Virus Variants

C.D.C. Announces $200 Million ‘Down Payment’ to Track Virus Variants

Scientists say the new investment will help in the next couple of months, but hope that the stimulus package will provide much more.

Dr. Rochelle Walensky, the C.D.C. director, speaking in December. Dr. Walensky laid out an ambitious program on Wednesday to track the numerous coronavirus variants circulating in the U.S.
Dr. Rochelle Walensky, the C.D.C. director, speaking in December. Dr. Walensky laid out an ambitious program on Wednesday to track the numerous coronavirus variants circulating in the U.S.Credit…Hilary Swift for The New York Times
  • Feb. 17, 2021, 4:57 p.m. ET

As lawmakers push for billions of dollars to fund the nation’s efforts to track coronavirus variants, the Biden administration announced on Wednesday a new effort to ramp up this work, pledging nearly $200 million to better identify the emerging threats.

Calling it a “down payment,” the White House said that the investment would result in a significant increase in the number of positive virus samples that labs could sequence. Public health laboratories, universities and programs run by the Centers for Disease Control and Prevention sequenced more than 9,000 genomes last week, according to the database GISAID. The agency hopes to increase its own contribution to 25,000 genomes a week.

“When we will get to 25,000 depends on the resources that we have at our fingertips and how quickly we can mobilize our partners,” Dr. Rochelle Walensky, the C.D.C. director, said at a White House news conference on Wednesday. “I don’t think this is going to be a light switch. I think it’s going to be a dial.”

The program is the administration’s most significant effort to date to address the looming danger of more contagious variants of the virus. A concerning variant first identified in Britain has infected at least 1,277 people in 42 states, although scientists suspect the true number is vastly higher.

Doubling about every 10 days, the B.1.1.7 variant that emerged in Britain threatens to slow or reverse the rapid drop of new coronavirus cases. What’s more, Dr. Walensky said that the nation had seen its first case of B.1.1.7 that had gained a particularly worrying mutation that has been shown in South Africa to blunt the effectiveness of vaccines.

Other worrisome variants have also cropped up in the United States, including one that was first found in South Africa and weakens vaccines.

The F.D.A. is preparing for a potential redesign of vaccines to better protect against the new variants, but those efforts will take months. In the short term, experts say, it is critical to increase sequencing efforts, which are too small and uncoordinated to adequately track where variants are spreading, and how quickly.

Scientists welcomed the new plans from the Biden administration. “It’s a huge step in the right direction,” said Bronwyn MacInnis, a geneticist at the Broad Institute.

Dr. MacInnis said that the “minimal gold standard” would be sequencing 5 percent of virus samples. If cases continue to fall, then 25,000 genomes a week would put the country near that threshold, she said, which is “where we need to be to be detecting not only known threats, but emerging threats.”

Trevor Bedford, an evolutionary biologist at the Fred Hutchinson Cancer Research Center, said there had been “substantial gains” in national sequencing efforts since December. Still, he said that the C.D.C. would also need to make improvements in gathering data about the genomes —such as tieing it to information from contact tracing — and then supporting the large-scale analysis on computers required to quickly make sense of it all.

Senator Tammy Baldwin, Democrat of Wisconsin, has pushed for more federal funding for variant detection.
Senator Tammy Baldwin, Democrat of Wisconsin, has pushed for more federal funding for variant detection.Credit…Alyssa Schukar for The New York Times

“There’s too much of a focus on the raw count that we’re sequencing, rather than turnaround time,” he said.

White House officials cast the sequencing ramp-up as part of a broader effort to test more Americans for the virus. The Department of Health and Human Services and the Defense Department on Wednesday announced substantial new investments in testing, including $650 million for elementary and middle schools and “underserved congregate settings,” like homeless shelters. The two departments are also investing $815 million to speed the manufacturing of testing supplies.

The C.D.C.’s $200 million sequencing investment is dwarfed by a program proposed by some lawmakers as part of an economic relief package that Democratic congressional leaders aim to pass before mid-March. Senator Tammy Baldwin, Democrat of Wisconsin, introduced legislation to enhance its sequencing efforts. House lawmakers have allocated $1.75 billion to the effort.

In an interview, Ms. Baldwin suggested that the government should be aiming to sequence 15 percent of positive virus samples, a goal far beyond what researchers believe is possible in the near term.

“This is intended to create the basis of a permanent infrastructure that would allow us not only to do surveillance for Covid-19, to be on the leading edge of discovering new variants, but also we’d have that capacity for other diseases,” she said of her proposal. “There’s significant gaps in our knowledge.”

Since 2014, the C.D.C.’s Office of Advanced Molecular Detection has used genome sequencing to track diseases like influenza, H.I.V. and food-borne diseases. But when the coronavirus pandemic struck the United States, the C.D.C. was slow to adapt these tools to track the coronavirus. For weeks it struggled simply to establish a test for Covid.

In contrast, Britain started a widely praised sequencing program last March, taking advantage of its nationalized health care system with a central genomics lab. It now sequences up to 10 percent of all positive Covid tests and delivers deep, rapid analysis of the results.

The C.D.C. began ramping up surveillance efforts over the course of 2020, helping academic labs, commercial sequencing companies and public health departments to collaborate and share insights. In November, it invested in a program of its own, called NS3, to analyze coronavirus genomes. Every other week, the agency asks state health departments to send at least 10 samples to its lab for sequencing.

In December, it became clear those efforts would not be enough. Researchers in Britain found a new variant, called B.1.1.7, that was up to 50 percent more transmissible than other variants. Scientists now suspect it is also probably more lethal. In South Africa, another variant called B.1.351 proved not only more contagious, but less vulnerable to several vaccines.

C.D.C. officials began to fear B.1.1.7 had already been spreading widely in the United States, according to one senior federal health official. They began setting up new efforts, including contracts with lab testing companies that were running Covid tests.

Lab technicians Angelica Garces, left, and Sarah Clarke, right, prepared to load human RNA samples into a sequencing machine at Duke University earlier this month.Credit…Pete Kiehart for The New York Times

Dr. Gregory Armstrong, the director of the Advanced Molecular Detection Program, said in an interview that his team came to the conclusion in January that sequencing from 5,000 to 10,000 samples a week would be a good short-term target.

“It’s the starting point,” Dr. Armstrong said. “The more we sequence above that, the more quickly we’ll be able to pick up these variants.”

At a White House news conference later that month, Jeffrey D. Zients, the White House’s Covid-19 response coordinator, acknowledged how difficult reaching that goal would be.

“We are 43rd in the world in genomic sequencing — totally unacceptable,” he said, citing December data from the GISAID database. In a subsequent interview, he corrected himself, saying that the U.S. was behind 31 other nations.

In the early days of the administration, Dr. Walensky spoke of an initial goal for the C.D.C. of sequencing 7,000 genomes a month. Since then, the labs have not come close to that figure.

The agency’s National Genomic Surveillance Dashboard showed that they logged just 96 genomes in the week of Feb. 6. The following week, the figure rose to 1,382 genomes. Dr. Walensky’s new target of 25,000 genomes a week will require a significant increase.

Caitlin Rivers, an epidemiologist at Johns Hopkins Bloomberg School of Public Health, said putting $200 million quickly into monitoring variants was a welcome development in advance of what she hoped would be longer-term improvements. “Time is of the essence,” she said. “An initial investment to expand genomic surveillance while the supplemental funding package comes together is a smart move.”

But she warned that the plan won’t be able to spring instantly into action. It may take a month just to get the basic improvements in place. By then, B.1.1.7 may already dominate U.S. cases and could jeopardize the current decline.

The larger program in the stimulus package will be crucial to managing the pandemic in the long run, Dr. Rivers said.

“We may not be able to get very far as relates to B.1.1.7, but what’s the next one, three months from now, or six months, or next winter?” she asked. “It’s not always just the thing in front of you. It’s what’s coming around the corner.”

Scientists Are Trying to Spot New Viruses Before They Cause Pandemics

Scientists Are Trying to Spot New Viruses Before They Cause Pandemics

Scientists want to build a weather system for viruses. It would require a big financial investment, plus buy-in from doctors, hospitals and blood banks.

Dr. Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health.
Dr. Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health.Credit…Kayana Szymczak for The New York Times

  • Feb. 15, 2021, 5:00 a.m. ET

Back in the summer, Dr. Michael Mina made a deal with a cold storage company. With many of its restaurant clients closed down, the firm had freezers to spare. And Dr. Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health, had a half-million vials of plasma from human blood coming to his lab from across the country, samples dating back to the carefree days of January 2020.

The vials, now in three hulking freezers outside Dr. Mina’s lab, are at the center of a pilot project for what he and his collaborators call the Global Immunological Observatory. They envision an immense surveillance system that can check blood from all over the world for the presence of antibodies to hundreds of viruses at once. That way, when the next pandemic washes over us, scientists will have detailed, real-time information on how many people have been infected by the virus and how their bodies responded.

It might even offer some early notice, like a tornado warning. Although this monitoring system will not be able to detect new viruses or variants directly, it could show when large numbers of people start acquiring immunity to a particular kind of virus.

The human immune system keeps a record of pathogens it has met before, in the form of antibodies that fight against them and then stick around for life. By testing for these antibodies, scientists can get a snapshot of which flu viruses you have had, what that rhinovirus was that breezed through you last fall, even whether you had a respiratory syncytial virus as a child. Even if an infection never made you sick, it would still be picked up by this diagnostic method, called serological testing.

“We’re all like little recorders,” keeping track of viruses without realizing it, Dr. Mina said.

Spotting Patterns

This type of readout from the immune system is different from a test that looks for an active viral infection. The immune system starts to produce antibodies one to two weeks after an infection begins, so serology is retrospective, looking back at what you have caught. Also, closely related viruses may produce similar responses, provoking antibodies that bind to the same kinds of viral proteins. That means carefully designed assays are needed to distinguish between different coronaviruses, for example.

But serology uncovers things that virus testing does not, said Derek Cummings, an epidemiologist at the University of Florida. With a large database of samples and clinical details, scientists can begin to see patterns emerge in how the immune system responds in someone with no symptoms compared to someone struggling to clear the virus. Serology can also reveal before an outbreak starts whether a population has robust immunity to a given virus, or if it is dangerously low.

“You want to understand what has happened in a population, and how prepared that population is for future attacks of a particular pathogen,” Dr. Cummings said.

The approach could also detect events in the viral ecosystem that otherwise go unnoticed, Dr. Cummings said. For example, the 2015 Zika outbreak was detected by doctors in Brazil who noticed a cluster of babies with abnormally small heads, born seven to nine months after their mothers were infected. “A serological observatory could conceivably have picked this up before then,” he said.

Freezers containing a half-million vials of plasma outside Dr. Mina’s lab at the Harvard T.H. Chan School of Public Health.
Freezers containing a half-million vials of plasma outside Dr. Mina’s lab at the Harvard T.H. Chan School of Public Health.Credit…Kayana Szymczak for The New York Times

Serological surveys are often small and difficult to set up, since they require drawing blood from volunteers. But for several years Dr. Mina and his colleagues have been discussing the idea of a large and automated surveillance system using leftover samples from routine lab tests.

“Had we had it set up in 2019, then when this virus hit the U.S., we would have had ready access to data that would have allowed us to see it circulating in New York City, for example, without doing anything different,” Dr. Mina said.

Although the observatory would not have been able to identify the new coronavirus, it would have revealed an unusually high number of infections from the coronavirus family, which includes those that cause common colds. It might also have shown that the new coronavirus was interacting with patients’ immune systems in unexpected ways, resulting in telltale markers in the blood. That would have been a signal to start genetic sequencing of patient samples, to identify the culprit, and might have provided grounds to shut down the city earlier, Dr. Mina said. (Similarly, serology would not be able to spot the emergency of a new virus variant, like the contagious coronavirus variants that were discovered in South Africa and England before spreading elsewhere. For that, researchers must rely on standard genomic sequencing of virus test samples.)

A Powerful Investment

The observatory would require agreements with hospitals, blood banks and other sources of blood, as well as a system for acquiring consent from patients and donors. It also faces the problem of financing, noted Alex Greninger, a virologist at the University of Washington. Health insurance companies would be unlikely to foot the bill, since serology tests are usually not used by doctors to treat people.

Dr. Mina estimated that the observatory would cost about $100 million to get off the ground. He pointed out that, according to his calculations, the federal government has allocated more than twice that much to diagnostics company Ellume to produce enough rapid Covid tests to cover the American demand for only a handful of days. A pathogen observatory, he said, is like a weather forecasting system that draws on vast numbers of buoys and sensors around the globe, passively reporting on events where and when they arise. These systems have been funded by government grants and are widely valued.

The predictive power of serology is worth the investment, said Jessica Metcalf, an epidemiologist at Princeton and one of the observatory team members. A few years ago, she and her collaborators found in a smaller survey that immunity to measles was ominously low in Madagascar. Indeed, in 2018 an outbreak took hold, killing more than 10,000 children.

Now, the half-million plasma samples in Dr. Mina’s freezers, collected by the plasma donation company Octopharma from sites across the country last year, are starting to undergo serological tests focused on the new coronavirus, funded by a $2 million grant from Open Philanthropy. Testing had to wait for the researchers to set up a new robotic testing facility and process the samples, but now they are working through their first batches.

The team hopes to use this data to show how the virus flowed into the United States, week by week, and how immunity to Covid has grown and changed. They also hope it will spark interest in using serology to illuminate the movement of many more viruses.

“The big idea is to show the world that you don’t have to spend huge dollars to do this kind of work,” Dr. Mina said. “We should have this happening all the time.”