Will the new 15 minute COVID-19 test solve US test problems?

(Conversation) On August 26, the Food and Drug Administration granted emergency approval for a new rapid antigen test for COVID-19 called the BinaxNOW test.

I’m studying public health policies to combat infectious disease epidemics. Testing is one of the most powerful tools available to combat the epidemic of COVID-19. The new tests are cheap, quick, and easy to use. While significantly expanding access to testing, there are still hurdles to achieving extensive and frequent COVID-19 testing.

What kind of test is BinaxNOW?

The credit card size test is an antigen test that detects specific viral proteins from SARS-CoV-2. It costs US$5 and does not require labs or processing machinery.

Running the test is easy. Healthcare professionals or technicians use swabs to collect samples from less than one inch in the nostrils. Then mix the sample with a few drops of the chemical in the test card. Within 15 minutes, the test strip will show a positive or negative result. This test can also be combined with apps that generate a digital code that can be scanned to show proof that a recent COVID-19 test is negative.

What can I do with an emergency license?

The BinaxNOW test is currently only allowed for patients with COVID-19 symptoms less than 7 days old. In this case, the virus level in the body may be high. It must be performed by a physician-prescribed, trained technician or other healthcare professional.

The COVID-19 PCR test is now widely used and considered the gold standard, but requires patient samples to be sent to the lab and results can take days. The new antigen test is designed as an inexpensive and rapid alternative to PCR tests for diagnostic purposes in the medical setting. This adds significant capacity to the expanded test system.

The emergency use permit provides a preliminary permit for physicians to prescribe an antigen test while the FDA’s full approval process is in progress. If the test is not as accurate or reliable as expected, approval may be revoked.

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How accurate is this test?

The health technology company Abbott, who created the test, reported that the test was consistent with the PCR test when patients had symptoms, with 97.1% for COVID-19 positives and 98.5% for COVID-19 negatives. I am. This is high enough for diagnostic settings where accuracy is important.

However, the true accuracy may be lower because the performance testing group is only 102 people and has not been verified for accuracy by FDA as part of the full approval process. Although the accuracy is not 100%, the BinaxNOW test will always produce some false negatives and false positives, but the FDA will monitor the data to make sure the test meets the reported accuracy.

Can this test be used for extensive screening?

The BinaxNOW test is cheap, fast, mass-produced and easy to use outside the lab. This makes it a promising candidate for extensive screening. However, the test is currently only allowed for people with COVID-19 symptoms.

This is a disorder because an estimated 40% of all COVID-19 cases are asymptomatic and it is likely that these people will not know they are infected. To maximize the effectiveness of the COVID-19 screening program, it is important to test for symptoms.

Healthcare providers can prescribe the BinaxNOW test for off-label use in asymptomatic patients, but health care providers will ask how accurate the test is in asymptomatic people. I don’t know

Is this test a game changer?

The significant increase in test access made possible by the BinaxNOW test almost certainly outweighs the downsides of a few inaccurate results. Abbott plans to manufacture 50 million tests each month from October. This quickly exceeds the 76 million COVID-19 tests that the United States has conducted in the last six months.

Extensive and frequent testing is effective in slowing the spread of coronaviruses. The new test capabilities enabled by this rapid antigen test approval represent a major advance in bringing the pandemic under control.

This article was republished from Conversation under the Creative Commons License. Read the original article here: https://theconversation.com/will-the-new-15-minute-covid-19-test-solve-us-testing-problems-145285..