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Tag: at-home tests

  • Will COVID’s Spring Lull Last?

    Will COVID’s Spring Lull Last?

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    By all official counts—at least, the ones still being tallied—the global situation on COVID appears to have essentially flatlined. More than a year has passed since the world last saw daily confirmed deaths tick above 10,000; nearly a year and a half has elapsed since the population was pummeled by a new Greek-lettered variant of concern. The globe’s most recent winters have been the pandemic’s least lethal to date—and the World Health Organization is mulling lifting its COVID emergency declaration sometime later this year, as the final pandemic protections in the United States prepare to disappear. On the heels of the least-terrible winter since the pandemic’s onset, this spring in the U.S. is also going … kind of all right. “I am feeling less worried than I have been in a while,” Shweta Bansal, an infectious-disease modeler at Georgetown University, told me.

    That sense of phew, though, Bansal said, feels tenuous. The coronavirus’s evolution is not yet predictable; its effects are nowhere near benign. This might be the longest stretch of quasi-normalcy that humanity has had since 2020’s start, but experts can’t yet tell whether we’re at the beginning of post-pandemic stability or in the middle of a temporary reprieve. For now, we’re in a holding pattern, a sort of extended coda or denouement. Which means that our lived experience and scientific reality might not match up for a good while yet.

    There is, to be fair, reason to suspect that some current trends will stick. The gargantuan waves of seasons past were the rough product of three factors: low population immunity, genetic changes that allowed SARS-CoV-2 to skirt what immunity did exist, and upswings in behaviors that brought people and the virus into frequent contact. Now, though, just about everyone has had some exposure to SARS-CoV-2’s spike protein, whether by infection or injection. And most Americans have long since dispensed with masking and distancing, maintaining their exposure at a consistently high plateau. That leaves the virus’s shape-shifting as the only major wild card, says Emily Martin, an infectious-disease epidemiologist at the University of Michigan. SARS-CoV-2 could, for instance, make another evolutionary leap large enough to re-create the Omicron wave of early 2022—but a long time has passed since the virus managed such a feat. Tentatively, carefully, experts are hopeful that we’re at last in a “period that could be kind of indicative of what the new normal really is,” says Virginia Pitzer, an infectious-disease epidemiologist at Yale.

    Top American officials are already gambling on that guess. At a conference convened in late March by the Massachusetts Medical Society, Ashish Jha, the outgoing coordinator of the White House COVID-19 Response Team, noted that the relative tameness of this past winter was a major deciding factor in the Biden administration’s decision to let the U.S. public-health emergency lapse. The crisis-caliber measures that were essential at the height of the pandemic, Jha said, were no longer “critical at this moment” to keep the nation’s health-care system afloat. Americans could rely instead primarily on shots and antivirals to keep themselves healthy—“If you are up to date on your vaccines and you get treated with Paxlovid, if you get an infection, you just don’t die of this virus,” he said. (That math, of course, doesn’t hold up as well for certain vulnerable groups, including the elderly and the immunocompromised.) The pharmaceuticals-only strategy asks much less of people: Going forward, most Americans will need to dose up on their COVID vaccines only once a year in the fall, a la seasonal flu shots.

    Making sweeping assessments at this particular juncture, though, is tough. Experts expect SARS-CoV-2 cases to take a downturn as winter transitions into spring—as many other respiratory viruses do. And a half-ish year of relative quietude is, well, just a half-ish year of relative quietude—too little data for scientists to definitively declare the virus seasonal, or even necessarily stable in its annual patterns. One of the most telling intervals is yet to come: the Northern Hemisphere’s summer, says Alyssa Bilinski, a health-policy researcher at Brown University. In previous years, waves of cases have erupted pretty consistently during the warmer months, especially in the American South, as people flock indoors to beat the heat.

    SARS-CoV-2 might not end up being recognizably seasonal at all. So far, the virus has circulated more or less year-round, with erratic bumps in the winter and, to a lesser extent, the summer. “There is a consistency there that is very enticing,” Bansal told me. But many of the worst surges we’ve weathered were driven by a lack of immunity, which is less of an issue now. “So I like to be extremely careful about the seasonality argument,” she said. In future years, the virus may break from its summer-winter shuffle. How SARS-CoV-2 will continue to interact with other respiratory viruses, such as RSV and flu, also remains to be seen. After an extended hiatus, driven largely by pandemic mitigations, those pathogens came roaring back this past autumn—making it more difficult, perhaps, for the coronavirus to find unoccupied hosts. Experts can’t yet tell whether future winters will favor the coronavirus or its competitors. Either way, scientists won’t know until they’ve collected several more years of evidence—“I would want at least a handful, like four or five,” Bansal said.

    Amassing those numbers is only getting tougher, though, as data streams dry up, Martin told me. Virus-surveillance systems are being dismantled; soon, hospitals and laboratories will no longer be required to share their COVID data with federal officials. Even independent trackers have sunsetted their regular updates. Especially abysmal are estimates of total infections, now that so many people are using only at-home tests, if they’re testing at all—and metrics such as hospitalization and death don’t fully reflect where and when the virus is moving, and which new variants may be on the rise.

    Shifts in long-term approaches to virus control could also upend this period of calm. As tests, treatments, and vaccines become privatized, as people lose Medicaid coverage, as community-outreach programs fight to stay afloat, the virus will find the country’s vulnerable pockets again. Those issues aren’t just about the coming months: COVID-vaccination rates among children remain worryingly low—a trend that could affect the virus’s transmission patterns for decades. And should the uptake of annual COVID shots continue on its current trajectory—worse, even, than America’s less-than-optimal flu vaccination rates—or dip even further down, rates of severe disease may begin another upward climb. Experts also remain concerned about the ambiguities around long COVID, whose risks remain ill-defined.

    We could get lucky. Maybe 2023 is the start of a bona fide post-pandemic era; maybe the past few months are genuinely offering a teaser trailer of decades to come. But even if that’s the case, it’s not a full comfort. COVID remains a leading cause of death in the United States, where the virus continues to kill about 200 to 250 people each day, many of them among the population’s most vulnerable and disenfranchised. It’s true that things are better than they were a couple of years ago. But in some ways, that’s a deeply unfair comparison to make. Deaths would have been higher when immunity was low; vaccines, tests, and treatments were scarce; and the virus was far less understood. “I would hope our standard for saying that we’ve succeeded and that we don’t need to do more is not Are we doing better than some of the highest-mortality years in history?” Bilinski told me. Perhaps the better question is why we’re settling for the status quo—a period of possible stability that may be less a relief and more a burden we’ve permanently stuck ourselves with.

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    Katherine J. Wu

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  • The Future of At-Home Testing: Flu, RSV Rapid Tests Are Coming

    The Future of At-Home Testing: Flu, RSV Rapid Tests Are Coming

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    Feb. 2, 2023 – It’s easy these days to take an at-home COVID test when you have symptoms like a fever and sore throat. But when the test is negative, the next step toward diagnosis usually means leaving the comforts of home.

    But that could soon change. The FDA says it is confident that at-home rapid tests like those for COVID-19 are forthcoming for the flu and respiratory syncytial virus, or RSV. 

    The division of the National Institutes of Health that helped create rapid COVID tests confirmed it is partnering with developers on combination tests that can look for multiple respiratory illnesses.

    Combination tests that can look for the markers of more than one disease are called multi-analyte. Europe and Australia already have over-the-counter tests that look for flu and RSV along with COVID-19.

    “We will be authorizing at-home flu and/or RSV tests that are multi-analyte with COVID,” an FDA official told WebMD. “I can’t tell you exactly when that would happen, but we are eager to do that.”

    Making such an at-home test possible would be in line with  the FDA’s goals to expand  health care equity and affordability, the official said. 

    Right now, the process for developing and applying for FDA approval of combination tests is less complicated and  expensive for developers under special pandemic rules. Developers get extensive assistance from the National Institute of Biomedical Imaging and Bioengineering at the NIH, particularly in the area of validation studies.

    The institute has already helped develop combination tests that can be used in health care settings, says  its director, Bruce Tromberg, PhD.

    “A couple of those have form factors that look like they should be fully at-home and over-the-counter,” he says “I’m optimistic that these will ultimately meet the performance bars that the FDA has.”

    Tromberg calls the current environment for at-home testing a “paradigm shift.” His institute estimates that more than 6.5 billion COVID tests that his organization helped create have been produced.

    “We’re actually going to probably stop counting, the numbers are just so big,” he says of the now universal  COVID test.

    From Test Tubes to Disposable Ubiquity

    With millions or even billions of COVID tests used, home testing is now commonplace in American life. 

    “The public’s expectations for medical testing are clearly being shaped differently due to the convenience, privacy, and speed of obtaining these results at home, which is a good thing,” Shannon Haymond, PhD, president of the American Association for Clinical Chemistry, wrote in an email. She is also the director of clinical mass spectrometry at the Ann & Robert H. Lurie Children’s Hospital of Chicago and an associate professor of pathology at Northwestern University Feinberg School of Medicine.

    With pandemic culture propelling demand for at-home testing, many are recalling the 1970s era known as the sexual revolution, which centered on women’s autonomy over their own bodies. During that time, pregnancy testing moved from the clinical setting to the privacy of women’s homes.

    “I really liked the term from, I think it was an EPT ad, from the ’70s that it was ‘a private little revolution,’” says historian Sarah Leavitt, PhD, a former historian at the NIH whose pregnancy test timeline, “The Thin Blue Line,” is one of the NIH’s most popular historical publications. “It brings the pregnancy test into your own private sphere, you have power over it again, and it’s your story and your body, and you can tell people when you want to.”

    Fifty years ago, the thin blue line wasn’t a 15-minute wait, which is about the time it takes these days to see the result of a pregnancy test or COVID test.

    “One big difference is that, when the first at-home pregnancy test hit the market in the 1970s, testing technology was a lot less advanced than it is today,” explained Haymond. “This means that the first home pregnancy test was very complicated to perform – it involved 10 steps and equipment like test tubes, and users had to keep the test tubes in a place free from vibrations for two hours. The easy-to-use stick tests that we’re familiar with today weren’t developed until 1988.”

    Both at-home COVID and pregnancy tests drew early concern from the medical community regarding test accuracy and potential for user error.

    “In retrospect, these concerns might seem overly cautious, but this push-pull between innovation and caution is integral to ensuring that medical advancements are made with patient safety foremost in mind,” Haymond said.

    The best approach is one that leverages the benefits of home testing with the expertise available from health care providers, who can advise when to test, how to interpret results, and determine if any extra medical care is needed, she said.

    The Future of At-Home Diagnostics

    Television can be a mirror for how science finds its place in our culture, Leavitt says. 

    “I was trying to envision when COVID tests will show up as a cultural marker in television shows,” she says, noting that beyond pregnancy tests, HIV tests and paternity tests have found their way into plots. “I don’t know what the plot point would be – maybe the test that’s found in the garbage and whose test was it?”

    By the time COVID tests show up in television, the pace of technology may have already brought a new forefront for at-home testing. Haymond foresees artificial intelligence on the horizon for at-home diagnostics.

    “Of course, like almost all areas of healthcare, we in laboratory medicine are anticipating data analytics as another major area of innovation and transformation,” she said. “This involves using technology such as artificial intelligence to find patterns and trends in healthcare datasets, and then using these findings to identify vulnerable patients before they become ill, better personalize testing and treatments, and augment human workflows in clinical testing and result interpretation.”

    In the more near-term, Tromberg at the National Institute of Biomedical Imaging and Bioengineering can envision a program that would help people in rural areas – sometimes called “health care deserts” – test at home and then easily be connected to care. The institute is already helping pilot such a program involving at-home COVID testing and connection to treatment in Pennsylvania. He could see a program like that easily using at-home flu and RSV tests.

    “People clearly would like to test at home if they could,” Tromberg says. “It’s not such a stretch, given that many people are already having telemedicine visits anyway.”

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  • How to Make Sense of This Fall’s Messy COVID Data

    How to Make Sense of This Fall’s Messy COVID Data

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    It is a truth universally acknowledged among health experts that official COVID-19 data are a mess right now. Since the Omicron surge last winter, case counts from public-health agencies have become less reliable. PCR tests have become harder to access and at-home tests are typically not counted.

    Official case numbers now represent “the tip of the iceberg” of actual infections, Denis Nash, an epidemiologist at the City University of New York, told me. Although case rates may seem low now, true infections may be up to 20 times higher. And even those case numbers are no longer available on a daily basis in many places, as the CDC and most state agencies have switched to updating their data once a week instead of every day.

    How, then, is anyone supposed to actually keep track of the COVID-19 risk in their area—especially when cases are expected to increase this fall and winter? Using newer data sources, such as wastewater surveillance and population surveys, experts have already noticed potential signals of a fall surge: Official case counts are trending down across the U.S., but Northeast cities such as Boston are seeing more coronavirus in their wastewater, and the CDC reports that this region is a hotspot for further-mutated versions of the Omicron variant. Even if you’re not an expert, you can still get a clearer picture of how COVID-19 is hitting your community in the weeks ahead. You’ll simply need to understand how to interpret these alternate data sources.

    The problem with case data goes right to the source. Investment in COVID-19 tracking at the state and local levels has been in free fall, says Sam Scarpino, a surveillance expert at the Rockefeller Foundation’s Pandemic Prevention Initiative. “More recently, we’ve started to see lots of states sunsetting their reporting,” Scarpino told me. Since the Pandemic Prevention Initiative and the Pandemic Tracking Collective started publishing a state-by-state scorecard of breakthrough-case reporting in December 2021, the number of states with a failing grade has doubled. Scarpino considers this trend a “harbinger of what’s coming” as departments continue to shift resources away from COVID-19 reporting.

    Hospitalization data don’t suffer from the same reporting problems, because the federal government collects information directly from thousands of facilities across the country. But “hospitalizations often lag behind cases by a matter of weeks,” says Caroline Hugh, an epidemiologist and volunteer with the People’s CDC, an organization providing COVID-19 data and guidance while advocating for improved safety measures. Hospitalizations also don’t necessarily reflect transmission rates, which still matter if you want to stay safe. Some studies suggest, for example, that long COVID might now be more likely than hospitalization after an infection.

    For a better sense of how much the coronavirus is circulating, many experts are turning to wastewater surveillance. Samples from our sewage can provide an advanced warning of increased COVID-19 spread because everyone in a public-sewer system contributes data; the biases that hinder PCR test results don’t apply. As a result, Hugh and her colleagues at the People’s CDC consider wastewater trends to be more “consistent” than constantly fluctuating case numbers.

    When Omicron first began to wreak havoc in December 2021, “the wastewater data started to rise very steeply, almost two weeks before we saw the same rise” in case counts, Newsha Ghaeli, the president and a co-founder of the wastewater-surveillance company Biobot Analytics, told me. Biobot is now working with hundreds of sewage-sampling sites in all 50 states, Ghaeli said. The company’s national and regional dashboard incorporates data from every location in its network, but for more local data, you might need to go to a separate dashboard run by the CDC or by your state health department. Some states have wastewater surveillance in every county, while others have just a handful of sites. If your location is not represented, Ghaeli said, “the wastewater data from communities nearby is still very applicable.” And even if your county does have tracking, checking up on neighboring communities might be good practice. “A surge in a state next door … could very quickly turn into a surge locally,” Ghaeli explained.

    Ghaeli recommends watching how coronavirus levels in wastewater shift over time, rather than homing in on individual data points. Look at both “directionality” and “magnitude”: Are viral levels increasing or decreasing, and how do these levels compare with earlier points in the pandemic? A 10 percent uptick when levels are low is less concerning than a 10 percent uptick when the virus is already spreading widely.

    Researchers are still working to understand how wastewater data correlate with actual infections, because every community has unique waste patterns. For example, big cities differ from rural areas, and in some places, environmental factors such as rainfall or nearby agriculture may interfere with coronavirus tracking. Still, long-term-trend data are generally thought to be a good tool that can help sound the alarm on new surges.

    Wastewater data can help you figure out how much COVID-19 is spreading in a community and can even track all the variants circulating locally, but they can’t tell you who’s getting sick. To answer the latter question, epidemiologists turn to what Nash calls “active surveillance”: Rather than relying on the COVID-19 test results that happen to get reported to a public-health agency, actively seek out and ask people whether they recently got sick or tested positive.

    Nash and his team at CUNY have conducted population surveys in New York City and at the national level. The team’s most recent survey (which hasn’t yet been peer-reviewed), conducted from late June to early July, included questions about at-home test results and COVID-like symptoms. From a nationally representative survey of about 3,000 people, Nash and his team found that more than 17 percent of U.S. adults had COVID-19 during the two-week period—about 24 times higher than the CDC’s case counts at that time.

    Studies like these “capture people who might not be counted by the health system,” Nash told me. His team found that Black and Hispanic Americans and those with low incomes were more likely to get sick during the survey period, compared with the national estimate. The CDC and Census Bureau take a similar approach through the ongoing Household Pulse Survey.

    These surveys are “a goldmine of data,” though they need to be “carefully designed,” Maria Pyra, an epidemiologist and volunteer with the People’s CDC, told me. By showing the gap between true infections and officially reported cases, surveys like Nash’s can allow researchers to approximate how much COVID-19 is really spreading.

    Survey results may be delayed by weeks or months, however, and are typically published in preprints or news reports rather than on a health agency’s dashboard. They might also be biased by who chooses to respond or how questions are worded. Scarpino suggested a more timely option: data collected from cellphone locations or social media. The Delphi Group at Carnegie Mellon University, for example, provides data on how many people are Googling coldlike symptoms or seeking COVID-related doctor visits. While such trends aren’t a perfect proxy for case rates, they can be a helpful warning that transmission patterns are changing.

    Readers seeking to monitor COVID-19 this fall should “look as local as you can,” Scarpino recommended. That means examining county- or zip-code-level data, depending on what’s available for you. Nash suggested checking multiple data sources and attempting to “triangulate” between them. For example, if case data suggest that transmission is down, do wastewater data say the same thing? And how do the data match with local behavior? If a popular community event or holiday happened recently, low case numbers might need to be taken with a grain of salt.

    “We’re heading into a period where it’s going to be increasingly harder to know what’s going on with the virus,” Nash told me. Case numbers will continue to be undercounted, and dashboards may be updated less frequently. Pundits on Twitter are turning to Yankee Candle reviews for signs of surges. Helpful sources still exist, but piecing together the disparate data can be exhausting—after all, data reporting and interpretation should be a job for our public-health agencies, not for concerned individuals.

    Rather than accept this fragmented data status quo, experts would like to see improved public-health systems for COVID-19 and other diseases, such as monkeypox and polio. “If we get better at collecting and making available local, relevant infectious-disease data for decision making, we’re going to lead healthier, happier lives,” Scarpino said.

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    Betsy Ladyzhets

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