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<ul class="summary-list"><li>Former Biden advisory member Dr. Celine Gounder told "Meet the Press" the <keyword id="11899468" type="UNKNOWN" weightage="60" keywordseo="fda" source="Orion">FDA</keyword> has "dragged its feet" in authorizing rapid antigen tests. </li><li>She said shifting guidelines from the <keyword id="11917544" type="UNKNOWN" weightage="60" keywordseo="cdc" source="Orion">CDC</keyword> and FDA are contributing to public confusion around prevention of the <keyword id="12616996" type="UNKNOWN" weightage="60" keywordseo="omicron" source="Orion">omicron</keyword> variant. </li></ul>Dr. Celine Gounder, a former advisory board member to the <keyword id="11908406" type="UNKNOWN" weightage="60" keywordseo="biden-administration" source="Orion">Biden Administration</keyword>, is speaking out about how organizations like the US Food and Drug Administration are contributing to public confusion around COVID-19 guidelines. Speaking on NBC's "Meet the Press" on Sunday, Gounder said that while the CDC has issued unclear guidance in recent weeks on how to prevent the spread of the omicron variant, there are "many other parties that contributed to this issue" — namely the FDA."The FDA under both the Trump and Biden administrations has really dragged its feet on authorizing these rapid antigen for the purpose of assessing 'are people contagious or not," Gounder said on Sunday.The <a href="https://www.businessinsider.com/cdc-director-explains-new-coronavirus-isolation-rules-2021-12">CDC recently faced criticism</a> for shifting its recommended isolation time periods, changing its guidance from 10 days to five days at the end of December. On Tuesday, the <a href="https://www.cdc.gov/coronavirus/2019-ncov/your-health/quarantine-isolation.html#:~:text=day%20of%20symptoms.-,If%20an%20individual%20has%20access%20to%20a%20test%20and%20wants%20to%20test%2C%20the%20best%20approach%20is%20to%20use%20an%20antigen%20test1%20towards%20the%20end%20of%20the%205%2Dday%20isolation%20period,-.%20Collect%20the%20test">CDC said</a> the "best approach" is to use a rapid antigen test toward the end of an isolation period, but <a href="https://www.cbsnews.com/news/cdc-guidelines-covid-test-isolation-quarantine/">stopped short of requiring a negative test to end isolation</a>.Similar to vaccines, the use of antigen tests to determine contagiousness must be authorized by the FDA before the CDC can formally include it in its isolation guidelines. Experts are advocating for rapid antigen tests as a good measure of whether a person is <a href="https://www.businessinsider.com/cdc-covid-19-symptoms-isolate-guidance-health-2022-1">infected with COVID</a> and contagious, Gounder said on Sunday, but the FDA has not yet approved them for that purpose. "We have real world evidence that the rapid antigen tests are a good measure of contagiousness but the FDA has not authorized them for that purpose," Gounder said on "Meet the Press."Still, the FDA has made significant moves in the fight against <keyword id="8764262" type="UNKNOWN" weightage="60" keywordseo="covid" source="Orion">COVID</keyword> in the past two months, including <a href="https://www.businessinsider.com/fda-oks-first-covid-19-pill-from-pfizer-2021-12">authorizing pills from Pfizer and Merck to treat COVID-19</a> and <a href="https://www.businessinsider.com/fda-approves-pfizers-covid-19-vaccine-booster-shot-teens-2022-1">approving the vaccine booster shot for children ages 12 and up</a>.Gounder also pointed out that the White House and private manufacturers could have been better prepared for the holiday season by place a large volume order of <keyword id="11996463" type="UNKNOWN" weightage="60" keywordseo="rapid-test" source="Orion">rapid test</keyword> in advance to create a "stabler demand." President Biden announced plans in late December to <a href="https://www.insider.com/biden-provide-at-home-covid-test-kits-omicron-2021-12">provide 500 million free at-home COVID tests</a> to help fight the Omicron surge, but <a href="https://www.latimes.com/california/story/2022-01-04/frustrating-hunt-for-covid-tests-long-lines-anxious-waiting">Americans are still struggling to find COVID tests</a>, as they scour empty shelves at pharmacies or navigate lengthy lines at testing sites. "The one and only thing you can count on is that the recommendations and guidelines are going to change over time," added Gounder.

FDA 'dragged its feet' in approving and providing rapid tests, former Biden advisory board member says

<ul class="summary-list"><li>New research suggests Omicron may be easier to detect in saliva than nasal samples.</li><li>Some experts recommend swabbing your throat then your nose for a COVID-19 <keyword id="11996463" type="UNKNOWN" weightage="60" keywordseo="rapid-test" source="Orion">rapid test</keyword>, even if the test doesn't say to.</li></ul>The FDA has authorized just one method of taking a COVID-19 rapid test: swabbing the inside of your nose.But ever since Omicron came into force in the US in mid-December, some people have noted <a href="https://twitter.com/Abbydietitian/status/1476610989126832132">on social media</a> that their rapid tests only come back positive after adding saliva to the mix. The anecdotes raised questions about whether throat swabs could increase a test's accuracy, or detect virus particles before a standard nose swab.Four disease experts told Insider they agree that it could be a good idea to throat-swab at home, even if the test doesn't call for it. But most recommended sticking the swab up your nose as well. "If you were my friend, I would say to you, 'Yeah, I would suggest that you swab your throat first and then your nose,'" Irene Petersen, an epidemiology professor at University College London, told Insider.If the test comes back positive, there's little reason to doubt the results, experts added. But since rapid tests were not designed to include a throat-swab, it doesn't hurt to verify the results with a lab-quality PCR test, said Susan Butler-Wu, who directs clinical testing for infectious diseases at the University of Southern California."I get why people are doing it," Butler-Wu said of throat swabbing. "I'd probably do it myself. But I would want to confirm if it was positive."<h2>Throat swabs haven't been vetted by the FDA for use at home</h2><div type="image" title="gloved person inserting rapid test swab into binax now card" height="1191" width="2100" msid="88743068" hostid="261"></div>Test manufacturers and US health agencies aren't recommending at-home throat swabs yet."The FDA advises that COVID-19 tests should be used as authorized, including following their instructions for use regarding obtaining the sample for testing," an FDA spokesperson told Insider, adding: "The FDA has noted safety concerns regarding self-collection of throat swabs, as they are more complicated than nasal swabs — and if used incorrectly, can cause harm to the patient."Abbott, one of the leading producers of rapid tests in the US, told Insider that its rapid test, BinaxNOW, should be used exclusively as a nasal swab because that's how it was designed."The test is highly accurate when used as intended," an Abbott spokesperson said.<h2>Why throat swabbing may help detect a positive case </h2><div type="image" title="man opening wide for saliva swab" height="1205" width="1606" msid="88743069" hostid="261"></div>Scientists have generally understood nasal swabs to be better at detecting respiratory viruses, including SARS-CoV2."The cells in the lining of the nose are much more similar to the cells deeper in the lungs," Sheldon Campbell, associate professor of laboratory medicine at Yale School of Medicine, told Insider. "That's traditionally why we've diagnosed all these viruses up in the nose."But it's possible <a href="https://www.businessinsider.com/covid-omicron-rapid-test-throat-nose-swab-miss-infection-experts-2022-1">the Omicron variant may change the way the coronavirus replicates or congregates</a> in the body.In a December <a href="https://www.medrxiv.org/content/10.1101/2021.12.22.21268246v1">study</a> that hasn't been peer reviewed, South African researchers found that saliva tests were better at picking up Omicron than nasal tests — detecting 100% of cases, while nasal swabs were only 86% sensitive. With Delta, the opposite was true: Saliva swabs were 71% sensitive, whereas nasal swabs were 100% sensitive.On Wednesday, a team of US researchers released another small <a href="https://www.medrxiv.org/content/10.1101/2022.01.04.22268770v1">study</a> — also not-yet-peer-reviewed — that supported those findings. They found that the viral load from an Omicron infection peaked in saliva one to two days before it peaked in nasal swabs. The study was based on samples from just 30 people. But these new results back up what <a href="https://mobile.twitter.com/conz/status/1476220981161177089">Twitter's</a> <a href="https://wgme.com/news/local/maine-cdc-swab-your-throat-instead-of-the-nose-with-at-home-test-kits">rogue citizen scientists have suggested</a> — that throat swabs might be detecting Omicron earlier in the course of a vaccinated person's illness than nasal swabs can.<h2>The throat may carry a higher viral load in Omicron's case</h2>Omicron's unique pattern of symptoms may offer more clues about where the variant prefers to hang out in the body.Tens of thousands of Omicron patients in the UK log their symptoms every day using the Zoe COVID app, <a href="https://youtu.be/AhTwYb3b99g?t=294">and 60% say they're suffering from a sore throat</a>, making it one of the top five symptoms there. Many of those patients also <a href="https://covid.joinzoe.com/post/omicron-and-cold-like-symptoms-rapidly-taking-over-in-london">report</a> that sore throat is one of their earliest symptoms. <a href="https://www.businessinsider.com/omicron-symptoms-cough-runny-nose-mild-us-europe-cdc-2021-12">Health officials in both the US and European Union</a> are, similarly, noting fewer instances of fever or loss of taste and smell with Omicron, when compared with other variants."It may be that Omicron is showing us a slightly different set of symptoms, and that may reflect perhaps a change in where this virus is infecting in your respiratory tract or how well it's infecting certain cells in your respiratory tract," Andy Pekosz, a virologist at the Johns Hopkins Bloomberg School of <keyword id="6364896" type="UNKNOWN" weightage="60" keywordseo="public-health" source="Orion">Public Health</keyword>, told Insider. "When you hear the same anecdotes from people that say a lot of them have a scratchy throat, it is probably because that's where the highest concentration of the virus is at that point," Petersen added. The variant, she said, "may colonize the tissues in the throat earlier than in your nose."That could, theoretically, be even more true now that "many people are vaccinated," she said, a potential early sign their vaccine-induced immunity is kicking in. "Therefore, they may develop symptoms very early on, when they still have very little viral material, especially in the nose."On the other hand, throat swabs might simply be picking up on drainage from the nose, Campbell said."It's not implausible that there's a fair amount of virus in the back of the throat — even if it's not replicating there, frankly, because everything runs down there from the nose," he said.<h2>How to perform a throat swab properly </h2><div type="image" title="woman swabbing throat in her car" height="1397" width="2100" msid="88743071" hostid="261"></div>If you're going to try swabbing your throat at home, there are a few key things to know. Many rapid tests in the UK use a combined throat/nose swab, and the UK Health Security Agency has a brief <a href="https://www.youtube.com/watch?v=5qHTBlxfNes">how-to video</a>.First, it's important not to drink, eat, or brush your teeth for at least 30 mins prior to performing the swab, because it's possible that could mess with your test results."We're talking about basically putting something onto a strip of special paper," Butler-Wu said of how the rapid antigen tests work. "So we worry more about random chemical interference, potentially."Next, always be sure to wash your hands thoroughly before testing. Then, stand in front of a mirror, and open wide. Stick out your tongue, so you can see the bridge-like, arched surface that extends across the roof of your throat. The area directly behind that bridge, where your <a href="https://training.seer.cancer.gov/anatomy/lymphatic/components/tonsils.html">tonsils jut out</a> on either side, is the place we're interested in sampling for virus. <a href="https://youtu.be/5qHTBlxfNes?t=149">Sweep across both tonsils, at the top of the very back of the mouth</a>, for several seconds. Avoid touching the tongue, teeth, or the insides of your cheeks with the swab.Be gentle, but <a href="https://youtu.be/S9XR8RZxKNo">swab judiciously back and forth across both tonsils firmly, at least four times</a>. Sampling this far back may activate your gag reflex, but it shouldn't hurt you. Then, proceed with your nose swab as usual. It's very important to swab your throat before your nose, because you don't want to introduce anything that may be stuck in your nose down your throat.Some experts said they expect manufacturers to come out with updated guidance for rapid tests soon, though Abbott declined to comment on whether that was the case. "Nobody's trying to dupe anybody," Butler-Wu said. "We're all thrown into this hot mess together trying to figure it out."

'Swab your throat first and then your nose': 4 disease experts offer new guidance on COVID-19 rapid tests

<ul class="summary-list"><li>Dr. <keyword id="12052715" type="UNKNOWN" weightage="60" keywordseo="jerome-adams" source="Orion">Jerome Adams</keyword> criticized the CDC's decision to cut the isolation time from 10 days to five days.</li><li>The change is for people who have tested positive for the coronavirus but remain asymptomatic.</li></ul>Former US Surgeon General Jerome Adams on Tuesday spoke out against the latest guidance from the Centers for Disease Control and Prevention, which recommended that asymptomatic people infected with the coronavirus complete their isolation period after five days.Adams — who served under President Donald Trump from 2017 to 2021 and was <a href="https://www.businessinsider.com/jerome-adams-surgeon-general-coronavirus-boosters-vaccine-mask-mandates-trump-2021-9">a prominent member of the White House coronavirus task force</a> in the former president's administration — said that people should take an antigen test and secure a negative result for the coronavirus before ending their quarantine.The former surgeon general went on to speak of his high regard for the CDC but said people who work at the agency would be reluctant to follow the new guidelines."I love the CDC. Grew up wanting to work there and have been one of their most ardent defenders. I never dreamed the day would come when I would advise people NOT to follow their guidance," <a href="https://twitter.com/JeromeAdamsMD/status/1475843927517417487">he tweeted</a>."But ask any of them. They wouldn't even follow it for their own family," he added.Adams' comments came after the CDC cut its recommended isolation time in half — from 10 days to five days — for asymptomatic people who test positive for the coronavirus.The agency said that the new guidelines were driven by <keyword id="11896083" type="UNKNOWN" weightage="60" keywordseo="science" source="Orion">science</keyword> that showed that the bulk of virus transmission transpired earlier in the infection period.But Dr. <keyword id="11976521" type="UNKNOWN" weightage="60" keywordseo="anthony-fauci" source="Orion">Anthony Fauci</keyword>, the nation's top infectious-disease expert, <a href="https://www.businessinsider.com/covid-isolation-fauci-shortened-cdc-work-jobs-economy-coronavirus-economy-2021-12">recently told</a> CNN the CDC changed the guidelines based on <a href="https://www.businessinsider.com/omicron-variant-percent-new-covid-19-cases-cdc-2021-12?r=US&amp;IR=T">the number of new cases fueled by the Omicron variant</a>, while emphasizing the need keep the economy from faltering."With the sheer volume of new cases that we are having and that we expect to continue with Omicron, one of the things we want to be careful of is that we don't have so many people out," Fauci said. "If you are asymptomatic, and you are infected, we want to get people back to jobs — particularly those with essential jobs to keep our society running smoothly."Fauci said the changes had been under consideration for some time and called the new guidelines "very prudent" at this point in the <keyword id="11893994" type="UNKNOWN" weightage="60" keywordseo="covid-19" source="Orion">COVID-19</keyword> pandemic.Adams — while continuing to push back against the agency's changes on Twitter — <a href="https://twitter.com/JeromeAdamsMD/status/1475826368176873476">stressed</a> the importance of testing."Regardless of what CDC says, you really should try to obtain an antigen test (I know - easier said than done) and confirm it's negative prior to leaving isolation and quarantine. There's not a scientist or doctor I've met yet who wouldn't do this for themselves/their family," he tweeted."Many who are defending/championing this policy on TV have told me privately if it were their family/workplace, they would want a 'test out' of isolation policy. This isn't about the best science — it's a compromise to keep the economy open in the face of inadequate tests," he added.The Trump administration was criticized by those who felt it put economic needs before safety. Axios <a href="https://www.axios.com/scoop-white-house-overruled-cdc-cruise-ships-florida-91442136-1b8e-442e-a2a1-0b24e9a39fb6.html">reported</a> Trump officials overruled the CDC's recommendation to extend a cruise-ship ban. And The Washington Post reported Trump appointees tried to <a href="https://www.washingtonpost.com/health/2021/04/09/cdc-covid-political-interference/">alter</a> CDC reports on the coronavirus to better align with Trump's optimistic views.With the rapid spread of the Omicron variant of the coronavirus, Americans have been lining up across the country to secure free tests and have scouted convenience stores looking for kits that are suddenly in short supply, an issue that President Joe Biden has <a href="https://www.businessinsider.com/covid-19-at-home-tests-biden-acknowledges-shortages-2021-12">committed to tackling</a> in the ensuing weeks.Adams on Tuesday <a href="https://www.wishtv.com/news/coronavirus/dr-jerome-adams-critical-of-new-cdc-guidelines/">told</a> Indianapolis' WISH-TV 8 that he was concerned by the message the CDC's decision sent to the general public."I'm worried now that they're saying that the people who have isolated for five days can end isolation. But what most of America will hear is that, 'Hey, isolation is done for everybody,'" he said. "It doesn't matter if you've got symptoms or not. It doesn't matter if you wear a mask because the guidance also says that for the second five days, you should be wearing a mask around everyone else."He added: "We haven't had a great mask compliance thus far, so I don't have a whole lot of confidence that people are going to wear a mask after they end isolation."Nearly 822,000 people had died of the coronavirus in the US as of Wednesday, with more than 53.4 million confirmed cases, <a href="https://coronavirus.jhu.edu/">according to Johns Hopkins University</a>.

Former Surgeon General Jerome Adams says CDC officials wouldn't follow the new guidance 'for their own family'

Hyderbad, Global <keyword id="6354750" type="COMPANY" weightage="20" keywordseo="health">health</keyword>care company GSK, non-profit agency working to end health inequity PATH, and <keyword id="9254290" type="UNKNOWN" weightage="20" keywordseo="vaccine-maker-bharat-biotech">vaccine maker Bharat Biotech</keyword> on Wednesday announced the signing of a product transfer agreement for malaria vaccine RTS,S/AS01E1. The agreement includes the transfer of manufacturing of the RTS,S antigen part of the vaccine and the grant of a license on all rights pertaining to the RTS,S/AS01 malaria vaccine to Hyderabad-based <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> International Ltd (BBIL). GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to Bharat Biotech. BBIL was selected through a comprehensive, competitive process undertaken by GSK and PATH, working in consultation with the <keyword id="6356311" type="COMPANY" weightage="20" keywordseo="World-Health-Organisation">World Health Organisation</keyword> (WHO), the vaccine maker said in a statement here. The RTS,S/AS01E malaria vaccine, developed by GSK for more than 30 years, and in partnership with PATH since 2001, is currently being piloted in regions of Ghana, Kenya, and Malawi under the Malaria Vaccine Implementation Programme (MVIP). Ministries of Health concerned are leading the implementation of the vaccine, which is being given to young children through the three countries' routine immunisation programmes, with WHO providing technical and scientific leadership, playing a coordinating role, and working in collaboration with GSK, PATH, and a range of <keyword id="10662236" type="UNKNOWN" weightage="20" keywordseo="other-partners">other partners</keyword>. RTS,S/AS01E is the first, and to date, the only malaria vaccine to have received a positive review by regulatory authorities (positive scientific opinion from the <keyword id="114599" type="COMPANY" weightage="20" keywordseo="European-Medicines-Agency">European Medicines Agency</keyword> and approval by the regulatory authorities of Ghana, Kenya, and Malawi for use in the MVIP). The first dose of the vaccine has reached more than 500,000 children since the pilots were initiated by Ministries of Health in the three participating countries in 2019. This agreement with BBIL is the result of efforts by GSK, PATH, and WHO to help ensure long-term sustainable vaccine supply, in the event of a WHO policy recommendation for broader use and a commitment of sustained funding. This builds on existing GSK commitments to donate up to 10 million RTS,S/AS01E doses for use in the pilot, and to supply up to 15 million doses annually until 2028 if the product is recommended for wider use by WHO. It is expected that by 2029, at the latest, BBIL will be the sole supplier of the vaccine, with GSK supplying the adjuvant AS01E to them. "With a child still dying of malaria every two minutes, helping secure the long-term future of the only vaccine available by working with an established leader like Bharat Biotech is vital for the continued fight against this devastating disease. GSK is delighted to sign this agreement with Bharat Biotech," said Thomas Breuer, GSK Vaccines Chief Medical Officer and Vaccines Global Health lead. "We at PATH are proud to be a part of this remarkable effort -- together with partners across Africa, GSK, and WHO -- to get to this point. Now, with the signing of this agreement with Bharat Biotech, we have an additional, new partner to help ensure that this vaccine can be more widely available for use in Africa, alongside other malaria interventions, in the years to come," said John Bawa, Africa Lead, Vaccine Implementation, PATH. "We salute the commitment by GSK, PATH, and partners, in developing a novel vaccine against malaria, a dreaded disease with more than 200 million cases worldwide. We are truly honoured to support this partnership and to provide global access to RTS,S/AS01E. With prior expertise in malaria research, WHO prequalified vaccines, supplied to more than 70 countries, Bharat Biotech is geared up for large-scale manufacturing, and to provide continuous long-term supply of this life-saving vaccine," Bharat Biotech Chairman and Managing Director Krishna M. Ella said. SEE ALSO: <a href="https://www.businessinsider.in/business/corporates/news/hindustan-unilever-third-quarter-profit-revenue-and-share-price/articleshow/80480554.cms?upcache=2">A timely deal with GSK closed during the lockdown has helped Unilever three quarters in a row in India</a> <a href="https://www.businessinsider.in/budget/news/a-playbook-for-budget-2021-to-boost-electronics-manufacturing-in-india/articleshow/80476759.cms">A playbook for Budget 2021 to boost electronics manufacturing in India</a> <a href="https://www.businessinsider.in/tech/news/bytedance-lays-off-employees-in-india-months-after-tiktok-ban-in-the-country/articleshow/80476721.cms">ByteDance lays off employees in India, months after TikTok’s ban in the country</a>

Bharat Biotech to make antigen for first-ever anti-malaria vaccine

<ul class="summary-list"><li><keyword id="10794537" type="UNKNOWN" weightage="60" keywordseo="vaccinex">Vaccinex</keyword> shares were up as much as 223% Friday on two project deals with <keyword id="6469017" type="UNKNOWN" weightage="60" keywordseo="pharmaceutical">pharmaceutical</keyword> companies. </li><li>Trading volume of 196 million shares outpaced the average daily volume of about 540,000. </li><li>The company did not disclose the value of the two deals. </li></ul><a href="https://markets.businessinsider.com/stocks/vcnx-stock">Vaccinex stock</a> rocketed up more than 200% Friday, propelled by two collaboration deals centered on using the <keyword id="45082" type="PERSON" weightage="60" keywordseo="biotech">biotech</keyword> company's <keyword id="6562600" type="UNKNOWN" weightage="60" keywordseo="AntiBody">antibody</keyword> discovery platform. Vaccinex, which focuses on <keyword id="6355291" type="UNKNOWN" weightage="60" keywordseo="Cancer">cancer</keyword> and neurodegenerative disease, said it signed multi-project deals with two unnamed "prominent" pharmaceutical companies. Financial terms of the deals were undisclosed. Shares jumped as much as 233% to an intraday high of $9.56 before the gains were pared to 150%. Trading volume of more than 196 million shares in late-morning action trumped the average volume of about 540,000 shares. The stock began this year at a little more than $2 each. The collaborations will use the company's ActivMAb technology which Vaccinex said has multiple applications that include discovering antibodies specific for complex membrane antigens. Shares of Vaccinex traded at $6.18 at 12:19PM E.T. on Friday.

Vaccinex stock soars 223% on partnership deals using its antibody discovery platform

<ul class="summary-list"><li>Diagnostic or polymerase chain reaction (PCR) tests are currently being used to diagnose patients with COVID-19. </li><li>Antibody tests allow for more accurate tracking of the spread of the <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword>. People who test positive for coronavirus antibodies can also donate plasma.</li><li>Antigen testing is not on the market yet, but Massachusetts-based E25Bio is among several companies seeking FDA approval for at-home test kits.</li><li><a href="https://www.businessinsider.com/?hprecirc-bullet">Visit Business Insider's homepage for more stories</a>.</li></ul>With new information released all the time, it can be difficult to keep track of how doctors are testing for the coronavirus.&amp;While identifying and treating infected patients is critical, some tests add to our greater understanding of the pandemic's size, impact, and direction. Here is a breakdown of the differences between diagnostic, antibody, and antigen testing.<h2>Diagnostic testing: the frontline defense</h2>A diagnostic or a polymerase chain reaction (PCR) test is used for someone suspected of being infected with the coronavirus, usually obtained through a nasal or throat swab. Due to the limited supply in the US, though, typically only people with severe symptoms are tested.<div type="image" title="Hailey Boland, 20, a certified nursing assistant at John C. Fremont Hospital, receives a test for COVID-19 on the first day of testing for Mariposa residents at the Mariposa Alternative School Gym in Mariposa on April 30, 2020." height="4480" width="6720" msid="75589120" hostid="261"></div>"This test is looking for the presence of viral genetic material indicating the person has a current infection and is likely infectious," epidemiologist Tista Ghosh told Insider."Pathogens can be seen directly in specimens from the patient, often using a microscope, or grown in the laboratory over a period of days to weeks," Stephen Berger, founder of <a href="https://www.gideononline.com/about/team/">the Global Infectious Diseases and Epidemiology Network</a>, said.<a href="https://spectrum.ieee.org/the-human-os/biomedical/diagnostics/how-do-coronavirus-tests-work">Nucleic acid tests</a>, which are more sensitive in early detection, have been used extensively during the current pandemic. Results can typically take at least one to two days, though more rapid versions are in development. While they can detect the virus in those who are asymptomatic, diagnostic tests present a <a href="https://www.medrxiv.org/content/10.1101/2020.02.11.20021493v2.full.pdf">false negative in about 30% of cases</a>. Patients are therefore tested twice before being confirmed as noninfectious.<h2><keyword id="9037219" type="UNKNOWN" weightage="60" keywordseo="antibody-testing">Antibody testing</keyword>: Are you immune?</h2>People who may have been infected and recovered <a href="https://www.cdc.gov/coronavirus/2019-ncov/testing/serology-overview.html">are checked for antibodies</a>, proteins the body creates to help fight off a particular infection.Coronavirus antibodies are generally not detectable until <a href="https://www.businessinsider.com/when-to-take-an-antibody-test-for-coronavirus-covid-19-2020-5">14 days after symptoms</a> began. "In most viral infections, specific antibodies can be detected for months to years following infection — and in many cases well into old age," says Berger.<div type="image" title="A strip running a coronavirus antibody test on a blood samples." height="683" width="1024" msid="75589121" hostid="261"></div>Once someone is confirmed to have the antibodies they're able to donate plasma to patients who are currently infected. But antibody testing is also used to gain a more accurate representation of the pandemic's overall impact.Widespread antibody testing can help track where the virus has spread and its fatality rate, and determine whether or not it's appropriate to ease a lockdown.Unlike the swab for diagnosis, antibody tests require a blood sample, usually through a finger prick.The blood is then examined for two types of antibodies: IgM antibodies, which develop early during an infection, and IgG antibodies, which are more likely to be detected after you've recovered and are a better indicator of at least partial immunity.IgM test results can be available in as little as 15 minutes, while IgG tests are sent away to a lab and <a href="https://www.hackensackmeridianhealth.org/HealthU/2020/05/02/covid-19-antibody-testing-pros-cons/">it can take up to a week for results</a>. But some clinics will only perform IgG blood tests because they're more reliable.Does having antibodies to the coronavirus mean you're immune? It's not clear."In theory, the presence of these antibodies indicates a person has a low likelihood of being infected again," Ghosh said. "But we do not yet know the degree of immunity or how long this immunity lasts."It's also not clear if antibody tests cross-react with antibodies of other, more common coronaviruses or if immunity provided by antibodies from one strain of the coronavirus extends <a href="https://www.businessinsider.com/why-the-coronavirus-mutations-are-actually-nothing-to-worry-about-2020-4">to another strain</a>.And a negative result doesn't necessarily mean you didn't have COVID-19. It could mean you have an active infection and just haven't built up any antibodies. Even without symptoms, you'd still be at risk for spreading the virus.The FDA has issued <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#sarscov2antibody">emergency use authorizations</a> to increase antibody testing for the. Currently, there are over 120 different tests on the market, but not all are effective."<a href="https://www.ucsf.edu/news/2020/04/417276/testing-tests-covid-19-antibody-assays-scrutinized-accuracy-ucsf-uc-berkeley">Early results</a> suggest that many of the serology tests on the market today are inaccurate and unreliable, and may have a high rate of false positives," Ghosh said. "So employers will need to carefully vet the quality of a given serology test before selecting a vendor, and will need to test employees multiple times to reduce the rate of false readings."On Monday, the FDA announced that companies have 10 days to <a href="https://www.nytimes.com/2020/05/04/health/fda-antibody-tests-coronavirus.html">prove the accuracy of their antibody tests</a> or risk removal from the market.<h2>Antigen testing: the path to reopening America</h2>While PCR tests pick up the coronavirus' genetic material, antigen tests register <a href="https://www.technologyreview.com/2020/04/24/1000486/antigen-testing-could-faster-cheaper-diagnose-covid-19-coronavirus/">surface proteins</a> on the virus. They're easier to spot, making testing quicker and cheaper, and potentially available for at-home use. "The presence of COVID-19 and many other viruses in patient specimens can be confirmed using these antigen tests, usually within minutes to hours," Berger said. "In COVID-19, the viral antigen will already be detectable at the first sign of disease. In fact, many patients will already excrete viral RNA for several days before there are any symptoms whatsoever."An antigen can only indicate if you are currently infected, not if you recovered from the virus.<div type="image" title="deborah birx" height="1333" width="2000" msid="75589122" hostid="261"></div>White House coronavirus response coordinator Deborah Birx indicated at a recent briefing that reliable antigen testing could help reopen America, <a href="https://abcnews.go.com/Health/antigen-versus-antibody-testing-covid-19/story?id=70409446">ABC News reported</a>. "There will never be the ability on a nucleic acid test to do 300 million tests a day or to test everybody before they go to work or to school," Birx said. "But there might be with the antigen test."There are no antigen tests currently on the market, but several companies are working on them. OraSure Technologies is developing a home kit that would allow users to test themselves with a saliva sample.<a href="http://www.e25bio.com/">E25Bio</a>, backed by MIT scientists, is seeking FDA approval for a rapid-response kit that could provide results within 15 minutes.<div type="image" title="E25bio testing strips." height="462" width="404" msid="75589123" hostid="261"></div>E25Bio's test resembles an over-the-counter pregnancy test: A nasal swab is taken, with the sample added to a solution and placed on a paper strip treated with artificial antibodies. If the test is positive for coronavirus, a colored indicator forms on the strip.While antigen tests ease and speed make them attractive, their lack of sensitivity does not: They've been found to miss about 15% to 20% of infections."If you're using this test to screen people to make sure that they're not infected, and that they go back to work or things like that, then you'd be giving people the message that they are not infected when actually they are — and therefore transmitting the new coronavirus," Jesse Papenburg, an infectious disease expert at McGill University, told <a href="https://www.npr.org/sections/health-shots/2020/04/30/847416695/a-next-generation-coronavirus-test-raises-hopes-and-concerns">NPR</a>.For an antigen test for coronavirus to really work, scientists must understand the biology and structure of the coronavirus, something they're only beginning to do.Read the original article on <a href="https://www.businessinsider.com/difference-between-coronavirus-antibody-and-antigen-test-2020-5">Business Insider</a>

The difference between diagnostic, antibody, and antigen tests for the coronavirus

Washington, May 9 (AP) US regulators have approved a new type of coronavirus test that administration officials have promoted as a key to opening up the country.The Food and Drug Administration on Saturday announced emergency authorization for antigen tests developed by Quidel Corporation of San Diego. The test can rapidly detect fragments of virus proteins in samples collected from swabs swiped inside the nasal cavity, the FDA said in a statement.The antigen test is the third type of test to be authorized by the FDA.Currently, the only way to diagnose active COVID-19 is to test a patient's nasal swab for the genetic material of the virus. While considered highly accurate, the tests can take hours and require expensive, specialized equipment mainly found at commercial labs, hospitals or universities.A second type looks in the blood for antibodies, the proteins produced by the body days or weeks after fighting an infection. Such tests are helpful for researchers to understand how far a disease has spread within a community, but they aren't useful for diagnosing active infections.Antigen tests can diagnose active infections by detecting the earliest toxic traces of the virus rather than genetic code of the virus itself.The FDA said that it expects to authorize more antigen tests in the future.Quidel said Saturday that the test can provide an accurate, automated result in 15 minutes. The FDA's emergency authorization "allows us to arm our health care workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment," Douglas Bryant, CEO of Quidel, said in a statement.A genetic material test by Abbott Laboratories used at the White House also takes about 15 minutes.The company said it specializes in testing for diseases and conditions including the flu and Lyme disease.Quidel stock has more than doubled in value since the beginning of the year, closing Friday at $158.60.The US has tried to ramp up testing using the genetic method, but the country's daily testing tally has been stuck in the 200,000 to 250,000-per-day range for several weeks, falling far short of the millions of daily tests that most experts say are needed to reopen schools, businesses, churches and other institutions of daily life.That's led White House adviser Dr Deborah Birx and other federal officials to call for a "breakthrough" in the antigen tests."There will never be the ability on a nucleic acid test to do 300 million tests a day or to test everybody before they go to work or to school, but there might be with the antigen test," Birx told reporters last month.Recently, the National Institutes of Health announced $1.5 billion in research grants aimed at fast-tracking the development of rapid, easy-to-use testing approaches - including antigen tests - by the fall. (AP) SCYSCY

US approves new coronavirus antigen test with fast results

<ul><li>The '<keyword id="10038985" type="UNKNOWN" weightage="20" keywordseo="antisera">antisera</keyword>' has been developed by the Indian Council of Medical Research (ICMR) in collaboration with a Hyderabad-based bio-pharmaceutical firm.</li><li>The pre-print version of the study regarding the development of the equine antisera has been posted on the Research Square platform. </li></ul>The <keyword id="682334" type="PERSON" weightage="20" keywordseo="Drugs-Controller-General-of-India">Drugs Controller General of India</keyword> has given permission for conducting Phase-1 human clinical trial for an "antisera" that was developed by injecting inactivated SARS-CoV-2 in horses and can be a potential treatment for COVID-19, ICMR officials said on Tuesday. The 'antisera' has been developed by the Indian Council of Medical Research (ICMR) in collaboration with a Hyderabad-based bio-pharmaceutical firm. "With Biological E Limited we have developed an horse 'antisera' and we have just got clearance for conducting clinical trials for that," ICMR Director General Dr Balram Bhargava said at press briefing on Tuesday. The 'antisera' is yet to undergo human clinical trials to establish safety and efficacy. Antisera are blood serum high in antibodies against specific antigens and are injected in humans to help kickstart the immune system to fight specific infections. "The ICMR and Biological E Limited, <keyword id="6354552" type="LOCATION" weightage="20" keywordseo="hyderabad">Hyderabad</keyword>, have developed highly purified antisera (raised in animals) for prophylaxis and treatment of COVID-19," the apex health research body had earlier said in a tweet. The pre-print version of the study regarding the development of the equine antisera has been posted on the Research Square platform. "The study provides evidence of the potential of generating highly purified F(ab')2 from equines against SARS-CoV-2 that can demonstrate consistent and high neutralisation activity," the study paper said. "Further, in-vivo testing for efficacy of this indigenously developed, cost effective product will pave the way to clinical evaluation. Additionally, being a donor independent method, this may prove as an efficient alternative to convalescent plasma for treatment of COVID-19 patients," it said. Earlier such measures were used for controlling several viral and bacterial infections. "Although, plasma recovered from patients experiencing COVID-19 could serve similar purpose, the profile of antibodies, their efficacy and concentration keep varying from one patient to another and therefore, make it an unreliable clinical tool for patient management," the ICMR had said in a tweet. "Standardisation achievable through equine sera based treatment modality thus stands out as yet another remarkable public health initiative supported by ICMR in the time of COVID-19," it said. As part of the study, 10 healthy horses were immunised with inactivated SARS-CoV-2 and after 21 days of immunisation, plasma samples were tested. The results of the plasma samples indicated presence of SARS-CoV-2 specific IgG antibodies as detected in ELISA with neutralising capacity. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/mobile/news/samsung-foxconn-and-pegatron-among-16-companies-to-get-government-nod-to-boost-mobile-manufacturing-in-india/articleshow/78525793.cms">Samsung, Foxconn and Pegatron among 16 companies to get government nod to boost mobile manufacturing in India</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/news/apple-just-announced-an-event-on-october-13-where-it-will-likely-unveil-the-iphone-12/articleshow/78520065.cms">Apple just announced an event on October 13 where it will likely unveil the iPhone 12</a>

DCGI nod to Phase-1 human trials of 'antisera' with potential to treat COVID-19

Welcome to <a href="http://newsletter.businessinsider.com/join/4np/dispensed-daily">Dispensed Daily</a>, your daily dose of <keyword id="6354525" type="UNKNOWN" weightage="100" keywordseo="healthcare">healthcare</keyword> news from Business Insider's healthcare editor Lydia Ramsey Pflanzer and the healthcare team. <a href="http://newsletter.businessinsider.com/join/4np/dispensed-daily">Subscribe here to get this newsletter in your inbox every weekday.</a>Hello,In today's <keyword id="6265204" type="UNKNOWN" weightage="60" keywordseo="dispensed">Dispensed</keyword>: <a href="https://www.businessinsider.com/convalescent-plasma-hyperimmune-globulin-treatment-coronavirus-patients-2020-8">a recap of how convalescent plasma works</a>, <a href="https://www.businessinsider.com/children-aged-12-and-over-should-wear-masks-who-says-2020-8">World Health Organization guidance on kids and masks,</a> and <a href="https://www.businessinsider.com/40-million-rapid-covid-antigen-tests-available-september-less-accurate-2020-8">15-minute coronavirus antigen tests are coming.</a>Plus, telehealth company American Well <a href="https://www.sec.gov/Archives/edgar/data/1393584/000119312520228478/d943395ds1.htm">dropped its S-1</a>. We'll be keeping tabs as the company looks to hold its initial public offering in the coming weeks. <h3><a href="https://www.businessinsider.com/convalescent-plasma-hyperimmune-globulin-treatment-coronavirus-patients-2020-8"><div type="image" title="Convalescent plasma covid 19" height="3332" width="4443" msid="77743922" hostid="261"></div></a></h3><h3><a href="https://www.businessinsider.com/convalescent-plasma-hyperimmune-globulin-treatment-coronavirus-patients-2020-8">The FDA just authorized convalescent plasma treatments for coronavirus patients — here's how the blood transfusions work</a></h3><ul><li>The FDA just issued an emergency authorization for <keyword id="8956772" type="UNKNOWN" weightage="60" keywordseo="convalescent-plasma">convalescent plasma</keyword> treatment for <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword>.</li><li>The therapy involves treating sick patients with the blood of those who have already recovered.</li><li><a href="https://www.businessinsider.com/covid-19-plasma-treatment-takeda-alliance-development-timeline-2020-6">Convalescent plasma is also the basis for a drug, hyperimmune globulin, which would deliver consistent antibody levels to patients.</a></li><li><a href="https://www.businessinsider.com/convalescent-plasma-hyperimmune-globulin-treatment-coronavirus-patients-2020-8">But more research is needed to show the treatment is fully safe and effective. </a></li></ul><a href="https://www.businessinsider.com/convalescent-plasma-hyperimmune-globulin-treatment-coronavirus-patients-2020-8">Read the full story from Aria Bendix here&gt;&gt;</a><h3><a href="https://www.businessinsider.com/children-aged-12-and-over-should-wear-masks-who-says-2020-8"><div type="image" title="Linda Mejia, 24, puts a mask on her two-year-old daughter Linda at California Hospital Medical Center’s Hope Street Margolis Family Center, amid the outbreak of the coronavirus disease (COVID-19), in Los Angeles" height="3644" width="4859" msid="77743927" hostid="261"></div></a></h3><h3><a href="https://www.businessinsider.com/children-aged-12-and-over-should-wear-masks-who-says-2020-8">The WHO just released specific mask guidance for kids as they gear up to return to school: children 12 and older should wear them as adults do</a></h3><ul><li>The World Health Organization just released guidance on whether kids should wear masks. </li><li>It's broken down into age groups: kids older than 12 should wear them, kids younger than 6 shouldn't, and for kids in between, it depends on a handful of factors.</li><li><a href="https://www.businessinsider.com/children-aged-12-and-over-should-wear-masks-who-says-2020-8">Mask-wearing has been a point of confusion for parents, since children don't tend to get intense coronavirus symptoms, but are nonetheless getting infected in huge numbers.</a></li></ul><a href="https://www.businessinsider.com/children-aged-12-and-over-should-wear-masks-who-says-2020-8">Read the full story from Blake Dodge here&gt;&gt;</a><a href="https://www.businessinsider.com/40-million-rapid-covid-antigen-tests-available-september-less-accurate-2020-8"><div type="image" title="covid testing czar giroir " height="1560" width="2081" msid="77743935" hostid="261"></div></a><h3><a href="https://www.businessinsider.com/40-million-rapid-covid-antigen-tests-available-september-less-accurate-2020-8">Millions of coronavirus tests that can deliver results in 15 minutes will be available in September, but they're less accurate</a></h3><ul><li>Millions of rapid <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> tests are slated to become available to people across the US next month.</li><li>The tests, which can yield results in around 15 minutes, are cheap and easy to produce, and require no lab work.</li><li>But they are generally not as accurate as laboratory PCR tests, and may need to be performed several times to get an accurate read on whether someone is actually sick.</li><li><a href="https://www.businessinsider.com/40-million-rapid-covid-antigen-tests-available-september-less-accurate-2020-8">"I would still say that distancing and outdoor air are your best friends," one expert said. </a></li></ul><a href="https://www.businessinsider.com/40-million-rapid-covid-antigen-tests-available-september-less-accurate-2020-8">Read the full story from Hilary Brueck here&gt;&gt;</a>More stories we're reading:<ul><li><a href="https://fortune.com/2020/08/18/facebook-nyu-discover-mri-scans/">Facebook and NYU found a way to make MRI's faster</a> (Fortune)</li><li><a href="https://www.businessinsider.com/nasa-asteroid-headed-toward-earth-before-november-election-2020-8">NASA: A fridge-size asteroid is headed toward Earth one day before the November election</a> (Business Insider)</li><li><a href="https://www.statnews.com/2020/08/24/straight-talk-on-the-fdas-tumultuous-weekend-and-new-questions-about-its-independence/">Stat News' Adam Feuerstein and Matthew Herper on the FDA's decision to give convalescent plasma emergency use authorization</a> (Stat News) </li><li><a href="https://www.businessinsider.com/science-debunked-6-myths-about-masks-stop-believing-them-2020-8">Wearing a mask doesn't reduce your oxygen levels, and 6 other mask myths you should stop believing now</a> (Business Insider)</li></ul>See you tomorrow! In the meantime, find me at <a href="mailto:lramsey@businessinsider.com">lramsey@businessinsider.com.</a><a href="http://newsletter.businessinsider.com/join/4np/dispensed-daily">Subscribe to this newsletter here.</a>- Lydia

What you need to know about convalescent plasma

<ul class="summary-list"><li>Rapid, on-site <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> testing is generally less accurate than tests which are sent back to labs for analysis.</li><li>But rapid <keyword id="8913051" type="UNKNOWN" weightage="60" keywordseo="Covid-19-testing">COVID-19 testing</keyword> is still a useful screening tool, especially if it's conducted frequently. It can be cheap, and it's fast.</li><li>A negative rapid test result may still need to be confirmed with a lab test before a person can assume they're virus-free.</li><li>A rapid test can't be used as a hall pass to get close to other people, or as reassurance that you're doing a good job preventing yourself from getting sick. The virus is still here.</li></ul>Every day, people around the world are becoming makeshift coronavirus detectives, putting long swabs into their mouths and noses, and spitting into straws.They're scouring for any rapid in-throat or in-nostril evidence that the novel coronavirus may be at hand — hunting for clear signs that they might have an infection of COVID-19, the disease caused by the virus. When test results from these swabs and tubes come back negative, minutes later, some go off to play club <a href="https://www.youtube.com/watch?time_continue=67&amp;v=R4EohtIn2BQ&amp;feature=emb_titlemb_title">soccer,</a> or <a href="https://www.usatoday.com/story/sports/2020/07/12/coronavirus-sports-leagues-burdening-covid-19-testing-resources/5404426002/">major</a> league <a href="https://www.wsj.com/articles/is-it-a-problem-that-sports-gets-fast-test-results-and-you-dont-11594897200">sports</a>. Others emerge from the comfort of their cars to attend <a href="https://www.nytimes.com/2020/08/16/style/does-rapid-covid-testing-work-weddings-parties.html">chic parties in the Hamptons</a>, or venture to<a href="https://www.youtube.com/watch?time_continue=47&amp;v=DCRK7frO-qo&amp;feature=emb_titlemb_title"> summer retreats</a>. The <a href="https://sleeplessthemusical.com/">cast and crew of the musical</a> "Sleepless" in the UK now <a href="https://www.bbc.com/news/entertainment-arts-53995747">takes coronavirus nose swab tests each morning,</a> before performing their socially-distanced shows.But <a href="https://www.fda.gov/media/140161/download">rapid diagnostic tests for COVID-19</a>, which range in cost from a <a href="https://covidtrackerct.com/about-salivadirect/">couple dollars</a> to several hundred and take as little as 15 minutes to yield results, are not fail-safe, nor are they a free pass to live as if the virus does not exist.<keyword id="6364896" type="UNKNOWN" weightage="60" keywordseo="public-health">Public health</keyword> experts caution that rapid COVID-19 tests may only pick up about 70 to 80% of all infected people they test."I would still say that distancing and outdoor air are your best friends," Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told Insider. "To me, that would provide me much more assurance that I was not going to either get infected, or infect others, than would a rapid-detection test." Yet from <a href="https://www.nytimes.com/2020/08/16/style/does-rapid-covid-testing-work-weddings-parties.html">luxe party</a> entrances to <a href="https://news.yale.edu/2020/08/15/yales-rapid-covid-19-saliva-test-receives-fda-emergency-use-authorization">pro sports locker rooms</a> and <a href="https://www.thejakartapost.com/travel/2020/08/13/indonesian-travelers-enjoy-convenience-of-covid-19-testing-at-airports.html">vacation hotspots</a>, gatekeepers are using these tests as a ticket to entry, briefly pausing to register a negative result before letting people go on their way.<div type="image" title="rapid coronavirus testing line ny" height="1582" width="2100" msid="78245698" hostid="261"></div>These tests would be better dispatched as crude monitoring and surveillance systems, aimed not at catching every single case of the virus and declaring people safe to party, but instead dealing with the virus's still-rampant spread across countries around the globe. "Point of care tests are extremely useful if you have symptomatic people, or if you're contact tracing, or if you're in a place like a nursing home where we're going to be testing repeatedly," US coronavirus testing czar Admiral <keyword id="9562854" type="UNKNOWN" weightage="60" keywordseo="brett-giroir">Brett Giroir</keyword> told Insider during a press call on August 19."You can lose a little sensitivity, which generally these tests do, because you're going to have repeat testing."Rapid tests tend to be less accurate than PCR diagnostic tests, which have taken days and (sometimes) weeks to get back from labs. Most of these <a href="https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-antigen">newer, faster turnaround tests</a> are hunting for the presence of antigens, bits of protein that sit on or in the virus, instead of doing a more in-depth scouring for the virus's genetic code, as the more accurate molecular tests do.The US Food and Drug Administration <a href="https://www.fda.gov/media/140161/download">cautions</a> that negative rapid test results may need to be confirmed with a more accurate lab test, and the <a href="https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html#table1">Centers for Disease Control and Prevention says</a> the tests are "generally less sensitive than viral tests." So far, only <a href="https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-antigen">four rapid antigen tests</a> have received emergency use authorization from the FDA. <h2>Negative test results can encourage risky behavior</h2><div type="image" title="covid abbott rapid test swab" height="1236" width="1648" msid="78245701" hostid="261"></div>Even if rapid test results are correct, when negative, they often lead people into drawing false conclusions that they're safe to take lots of risks without consequence."It does send a message basically that if you're negative at this point, you must be doing something right," Osterholm said. "When I would say [if] you're negative at this point, you might just be lucky, and your luck's going to run out."Giroir stressed that the incubation period for the virus can often stretch to seven days before people get sick."If you're closely exposed to a [sick] person, if you get a test on day three, it's negative, it doesn't mean you're going to be negative on day four, day five, or day seven, or day 10, or day 12," he said. "So it still does not obviate your strict adherence to physical distancing, wearing a mask, avoiding crowded places. Do not risk the vulnerable." <h2>Rapid tests are still helpful screening tools</h2><h2><div type="image" title="free rapid covid test india" height="1467" width="2200" msid="77679034" hostid="261"></div></h2>Giroir expects several more rapid tests to be green-lit for emergency use by the FDA soon — enough to have 40 million point of care tests (the kind that don't need to be rushed off to a <a href="https://www.businessinsider.com/how-coronavirus-throat-tests-work-rt-pcr-method-explained-2020-4">lab's PCR machine</a>) available by the end of September. "Random testing of healthy people, just all over the country, is not what we're advocating for," he said. "All tests need to be used for the right person, at the right time, in the right situation."In addition to the rapid <keyword id="177408" type="PERSON" weightage="60" keywordseo="Antigen">antigen</keyword> tests, teams of <a href="https://news.yale.edu/2020/08/15/yales-rapid-covid-19-saliva-test-receives-fda-emergency-use-authorization">scientists at Yale</a> and at the <a href="https://news.uillinois.edu/view/7815/1904934500">University of Illinois</a> have also been developing simple <a href="https://news.illinois.edu/view/6367/1795135071">spit test protocols that</a> don't require people to succumb to intrusive, almost brain-scratching nose and throat swabs. Instead, test-takers expel their saliva into vials, and then that material is tested for the virus in a lab — a process that can take anywhere from several hours to more than a day. The tests, which <a href="https://covidtrackerct.com/about-salivadirect/">should cost about $10</a> for labs to process, aren't meant to be precise. "We're using the increase for frequent testing of different populations so that we can get a handle on this virus," Anne Wyllie, one of the researchers behind Yale's new SalivaDirect test protocol, said."This is definitely more for screening," she said of the protocol, which could "remove infectious people from the chain of transmission."The SalivaDirect method (which is a procedure other labs can copy and use, and not a testing kit) got FDA emergency use approval in August. It could be most useful for "frequent testing" Wyllie said, like at schools, workplaces, and on sports teams.Saliva, Wyllie said "can be tricky to work with," but the process she's developed skips some of the usual steps of other lab testing for the coronavirus, and she's hopeful that the ease of collecting spit will help speed diagnoses up, especially in the critical early days of an infection."Imagine if they had overnight labs running, and you deposited your saliva sample before you went to bed at night," she said. "Then your results were out by the morning."Even if these kinds of screening measures pick up just seven in every 10 coronavirus cases they test, that's far better than picking up none.But it's still not an indication that it's safe to get cozy again with whoever you want. This story was originally published on August 21, 2020. It has been updated as the FDA approves more antigen tests for emergency use.

Rapid coronavirus tests can give results in 15 minutes, but they aren't a pass for partying or seeing your parents

<ul class="summary-list"><li><keyword id="15091" type="CITY" weightage="60" keywordseo="Ohio">Ohio</keyword> Gov. <keyword id="1598215" type="PERSON" weightage="60" keywordseo="Mike-DeWine">Mike DeWine</keyword> tested positive for <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword> on August 6, but subsequent tests came back negative.</li><li>Speaking to CNN, the Republican governor said the experience points to issues that exist with rapid <keyword id="177408" type="PERSON" weightage="60" keywordseo="Antigen">antigen</keyword> tests.</li><li>Last week, DeWine and six other governors announced plans to <a href="https://www.businessinsider.com/us-governors-band-together-to-purchase-covid-19-testing-equipment-2020-8">pool their purchasing power</a> to obtain hundreds of thousands of antigen tests.</li><li>Asked if he was going ahead with that plan, DeWine told CNN that "we've not made a decision."</li></ul>Ohio Gov. Mike DeWine is more skeptical of antigen COVID-19 tests after himself receiving a false positive last week."If anyone needed a wake up call about antigens, how careful we have to be, we certainly saw that with my test," DeWine told CNN in <a href="https://www.cnn.com/videos/politics/2020/08/09/mike-dewine-coronavirus-tests-bash-sotu-vpx.cnn/video/playlists/this-week-in-politics/">an interview on Sunday</a>.The Republican governor's positive test result made headlines on Thursday, just hours before President Trump was set to land in his state. But subsequent tests came back negative."I think what people should not take away from my experience is that testing is not reliable or does not work," DeWine told CNN. Rather, the lesson is that the antigen method, which can return results in under 20 minutes, should be "looked at as a screening test," not the final word.Last week, <a href="https://www.businessinsider.com/us-governors-band-together-to-purchase-covid-19-testing-equipment-2020-8">Business Insider reported</a> that DeWine and six other governors had entered into an interstate compact to obtain hundreds of thousands of antigen tests.Asked about that compact on Sunday, and whether he plans to go ahead with the purchase of such tests, DeWine demurred. "We've not made a decision," he said.Have a news tip? Email this reporter: <a href="mailto:cdavis@insider.com">cdavis@insider.com</a>

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