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7;s one main reason why a fall without football is a real possibility: there are no reliable COVID-19 tests. We break down why.

USA TODAY

The Food and Drug Administration opened its doors on Wednesday for COVID-19 testing, which can be quick, cheap and completely done at home – unless companies find the rules too onerous.

Routine screening of people who do not know they have COVID-19 can change the fight against the disease.

“These types of tests will change the game in the fight against COVID-19 and will be crucial when the nation plans to launch an upgrade,” the FDA commissioner said in a statement announcing how the agency will approve the tests at home. Stephen Hahnas. .

To date, the FDA has not allowed anyone to sell the test at home.

Laboratory tests to detect coronavirus are accurate, but they are often prescribed to people with symptoms of COVID-19. The results often take several days – by which time the person may have infected others.

Other tests are quick, but such expensive ones are unlikely to be used on a regular basis. A Massachusetts clinic, for example, charges $ 160 for a quick trial; it is not insured.

People with COVID-19 become infected several days before and after the onset of symptoms.

Screening at home, perhaps once or twice a week, would allow people to test themselves before going to work or school, boarding a plane, attending an event, or visiting an elderly relative. If you let people know that they are being infected in real time, they could quarantine themselves, which would allow others to live their daily lives without risking infecting others.

Test interval: A quick, inexpensive test would help stop COVID-19. So why don’t we have them?

Daily updated coronaviruses: Subscribe to our newsletter now.

Will FDA rules encourage or discourage companies from developing in-house tests?

Several testing experts, including Dan Larremore of the University of Colorado, said the FDA is a step in the right direction and could encourage companies to conduct inexpensive, rapid tests at home.

Infectious Disease Epidemiologist from Harvard TH Chan School of Public Health dr. Michael Mina argued that the way the FDA recommendation template is written makes such important tests less likely to reach the general public.

The template explains how the sample is to be taken and analyzed and how the results are to be shown to the user, no need to send the sample to the laboratory for analysis.

The template also describes how accurate the tests should be to slightly lower standards than the labs.

“THE [required] the software alone will be an incredibly big hurdle for many, Mina said in an email. “Unfortunately, the template does not offer the ‘new’ path that I think will be needed if we really want $ 1 tests to become a reality every day.”

Mina said the standards should be further lowered. People become infected only when they have a particularly high level of the virus in their body, which can be detected by a less sensitive test. The infection, which will not undergo a less sensitive test, will be caught a few days after the person is re-screened, he said. Or the person would already be on the way to recovery and would most likely not be contagious.

Similar rapid tests used to diagnose tape bloating miss as many as one in five infected people, so doctors typically send a throat culture to a lab to confirm the diagnosis, Dr. Emily Volk, President of the American College of Pathologists. . Such a confirmatory test usually takes several days.

Doing so with COVID-19 could prevent traditional testing rather than facilitate it.

Race to create a fast, cheap COVID-19 test

There are several tests near the market that are fast and relatively cheap, but none of them live up to Mina’s vision: A quick test that costs just $ 1 and can provide an answer before someone leaves home in the morning.

The nonprofit organization XPRIZE, which develops and runs public competitions, announced on Tuesday that it will award a $ 5 million prize among five winners who can complete a test that results in just 15 minutes and costs less than $ 15. The winners will also share $ 50 million for a rapid increase in production, said Jeff Huber, president and founder of OpenCovidScreen, a company that is launching the competition in partnership with XPRIZE.

The competition runs until the end of August. About 200 semi-finalists will be selected. They will defeat 20 finalists, followed by five winners.

Applicants will be required to meet criteria that will expedite FDA approval. They will get expert advice from large test companies, Huber said. The five winners will be ready to expand production by the end of the year, he said.

Fertility doctors prepare a coronavirus test

Another approach to innovative testing is Sorrento Therapeutics of San Diego’s licensed technology developed at Columbia University in New York.

Dr. Zeev Williams, director of the Columbia University Fertility Center, has been developing tests for years that have helped couples with genetic diseases or recurrent miscarriages produce healthy babies. During the early pandemic, Williams said his team concluded that finding the genetic signature of the virus that caused COVID-19 was not that different.

The technology they developed is essentially looking for that genetic signature in a saliva sample. The sample is placed in a container with enzymes that, when heated, turn red to remove viruses or yellow to cause infection. The test is as accurate as the current standard, called the PCR test, which relies on expensive laboratory equipment, said Henry Ji, CEO of Sorrento and one of the key partners.

The company expects the test, which has not yet received FDA approval, to cost about $ 10, said Mark Brunswick, the company’s senior vice president of regulatory affairs.

Testing Company Officer: FDA “Moves Goalkeeper Pillars”

In the third version, Intrivo Diagnostics in Santa Monica, California and Access Bio Diagnostics in Somerset, New Jersey, are collaborating to develop and distribute a rapid test at home. Michael Harbor, Intrivo’s chief medical officer, said he expects the FDA approval process to be completed within the next 90 days.

Their examination provides a finger prick device and analyzes a drop of blood. The blue line indicates a positive viral virus; no line will be completely clear.

The test should be accurate enough to meet FDA guidelines, Harbor said. Companies are willing to perform tests as required by the FDA to make sure the test is easy enough for most people. He said he didn’t know how much it would cost.

The FDA, according to the Port, has “moved to targets” several times, requiring test companies to adhere to one protocol and then another. However, he hopes it is now clear how important this type of study will be to keep the virus under control.

“If the FDA is reasonable,” he said, “they will take action soon to make them available.”

Contact Karen Weintraub by email. Email kweintraub@usatoday.com

Ensuring health and patient safety in the U.S. TODAY is made possible in part by support from the Masimo Foundation for healthcare ethics, innovation, and competition. Masimo Foundation does not provide editorial information.

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