Recent Developments in COVID-19 Diagnostic Testing

FDA
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US boosts efforts to get test kits to labs that need them most, more tests get EUA approval

One major challenge in the US response to the novel coronavirus pandemic has been the availability of test kits and the reagents required to use those kits. Public health authorities say accurate and widespread testing is critical in identifying COVID-19 hotspots and how it is spreading, as well as ensuring infected patients are treated quickly.

But, as recently as last week, the US had only 23 test kits per million people, according to Dr. Paul Biddinger, MD, FACEP, of Boston’s Massachusetts General Hospital (MGH), speaking in a webinar broadcast Mar. 13. “It’s hard to say we have a handle on the situation when we just can’t test,” said Biddinger, chief of MGH’s Division of Emergency Preparedness and director of the hospital’s Center for Disaster Medicine.

However, authorities are moving quickly to close that gap and ramp up testing capacity.

On Mar. 16, the US Food & Drug Administration (FDA) announced they are eliminating regulatory hurdles around the development and release of diagnostic tests for COVID-19, the disease caused by the SARS-CoV-2 coronavirus.

The move by the FDA involves three main elements:

Allows states to take responsibility for diagnostic tests developed and used by labs in their states without having to go through the FDA

Expands the Feb. 29 guidance originally released for COVID-19 diagnostic testing to include commercially developed tests

Provides recommendations to manufacturers wanting to develop serological tests for COVID-19

Since the end of January, the FDA has being working with more than 100 diagnostic test developers. The regulator has helped more than 80 of those developers with tests they plan to bring through the FDA’s Emergency Use Authorization (EUA) process. As the COVID-19 situation is changing day by day, the FDA is asking that labs with questions about the EUA process, getting key supplies, or FDA policies call their toll-free line, 1-888-INFO-FDA.

At the moment, it’s not known how many test kits are now available as “this number fluctuates daily as more and more test developers get their tests in the field and start testing patients,” the FDA said in their Monday statement. “At this time, the FDA is focused on making sure tests are distributed and that test developers and labs have the materials they need to run the tests.”

As of early Mar. 19, seven commercial developers and two non-commercial developers had received EUA authorization for certified clinical labs to use their tests. Thermo Fisher Scientific and Roche Molecular Diagnostics were the first commercial developers to receive the go-ahead late last week. Roche plans to ship 400,000 of its cobas® SARS-CoV-2 tests for COVID-19 each week to labs authorized to run COVID-19 testing. Thermo Scientific also received authorization to distribute its real-time PCR (RT-PCR) diagnostic kits on Mar. 13 and plans to produce 5 million of those tests a week by April.

There are many more tests currently in development, including a new point-of-care test from California-based Fluxergy that may deliver results within 60 minutes and two tests from PathogenDx—one is a respiratory test that detects influenza A and B as well as COVID-19 and COVID mutations and the other focuses on air and surface environmental transmission, the company said in an email.

Limitations of key testing methods:

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. Though manufacturers now have the go-ahead to develop serological tests, which measure the amount of proteins or antibodies responding to infection in a patient’s blood, it’s unclear how many developers will choose to do so. In their Mar. 16 statement, the FDA admitted these tests “are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis.”

COVID-19 diagnostic tests currently available in the US that have been granted EUA (as of early Mar. 23):

Abbott Molecular Abbott RealTime SARS-CoV-2 Assay

CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel

Cepheid Xpert Xpress SARS-CoV-2 test

DiaSorin Molecular Simplexa COVID-19 Direct

GenMark Diagnostics ePlex SARS-CoV-2 Test

Hologic Panther Fusion® SARS-CoV-2 Test

Laboratory Corporation of America, COVID-19 RT-PCR Test

New York SARS-CoV-2 Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Wadsworth Center, NYSDOH)

Primerdesign Primerdesign Ltd COVID-19 genesig Real-Time PCR assay

Quest Diagnostics Infectious Disease Quest SARS-CoV-2 rRT-PCR

Quidel Lyra SARS-CoV-2 Assay

Roche Molecular Diagnostics cobas® SARS-CoV-2

Thermo Scientific TaqPath COVID-19 Combo Kit

Other companies are stepping up to provide quick access to lab automation products for COVID-19 diagnostic testing and products for COVID-19 research, including Hamilton Robotics, Microbiologics, and AMSBIO.

As the COVID-19 situation is evolving rapidly, be sure to reach out to the FDA or your local regulatory agency for the most up-to-date information on COVID-19 diagnostic tests.

Recent Developments in COVID-19 Diagnostic Testing