Monday, 06 April, 2020


Coronavirus outbreak: FDA approves new COVID-19 test kit

Epoch Times A laboratory technician uses Hologic’s new coronavirus test in a file
Kristine Garrett | 21 March, 2020, 01:48

This action demonstrates the FDA's ability to pivot and adapt as the situation warrants in light of a public health emergency.

"With no known treatment or approved vaccine for the highly-infectious COVID-19, the need for accurate and rapid diagnoses has never been greater".

The list will be updated as more kits are approved for commercial distribution in the country. In addition, more than 30 laboratories have notified FDA that they are testing, or intend to begin testing soon, laboratory developed tests (LDTs) for COVID-19. Companies and labs that are developing COVID-19 tests no longer have to wait to receive approval for emergency use authorization from the FDA for the tests. As stated in the guidance, the system does not need to mirror that of NY.

In fact, health experts are also on board for home coronavirus testing in the U.S. In a recent paper published in JAMA Health Forum, two doctors laid out the possible benefits of making these at-home tests available. Roche's test also is authorized for use in CLIA labs performing moderate complexity tests.

Roche expects to manufacture about 1.5 million tests per month.

Second, FDA has indicated that it will not object to a commercial manufacturer's distribution of SARS-CoV-2 diagnostic kits (i) after validation and notification to the agency, (ii) for a reasonable time (about 15 business days), (iii) while preparing an EUA request, (iv) provided that the manufacturer posts instructions for use and data regarding performance of the kit on its website. In their March 16 statement, the FDA admitted these tests "are less complex than molecular tests and are exclusively used to identify antibodies, which limits their effectiveness for diagnosis". Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection.

The FDA says more than 90 test developers have sought its assistance thus far. We've granted multiple diagnostic EUAs during this outbreak.

RT-PCR-based tests for COVID-19 seem to be the most common available from developers and while very sensitive, they do have some issues that could affect accuracy.

The CDC said it had tested 32,000 people in the U.S., or 0.01% of the population. This number fluctuates daily as more and more test developers get their tests in the field and start testing patients.

However, the FDA's updated guidelines drew concern from organizations such as the American Association for Clinical Chemistry (AACC), which feels that the Families First Coronavirus Response Act does not provide coverage for COVID-19 testing unless the tests are performed under an EUA.

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