INSUBCONTINENT EXCLUSIVE:
On Thursday, the FDA amended their emergency policy around diagnostic testing for SARS-CoV-2, the novel coronavirus that causes COVID-19
Following on a change made March 16, the agency opened the door for a number of specific private entities and labs to develop and distribute
tests that can provide results on the spot in as little as 15 minutes — but there are some pretty big caveats to keep in mind as you hear
about more of these coming to market.
The tests, which are &serological,& meaning they identify the presence of antibodies in a person
blood, differ considerably from the molecular testing that is currently in use under Emergency Use Authorization (EUA) by FDA-approved labs
and drive-through testing sites
The serological tests show that a person has developed antibodies to SARS-CoV-2, which means they very likely came into contact with it (and
either have it, or have already recovered from having it)
The molecular tests actually detect the presence of viral DNA in the blood stream, which is a much more definitive indicator that they
currently have an active infection (at least at the time the swab was taken).
Serological tests have still been used widely in countries
where the response to the COVID-19 pandemic has been shown to be effective, including in China, Taiwan and Singapore
They&ve also been used in different communities in the United States , based on earlier guidelines around private lab diagnostics
But on March 26, the FDA named 29 entities that provided notification to the agency as required and are now therefore able to distribute
their tests.
It important to note that these tests have not been reviewed or validated by the FDA, unlike those molecular tests that are
included in the organization emergency use category
Instead, the FDA &does not intend to object to the development and distribution by commercial manufacturers& of these tests, provided they
meet a number of criteria, including qualifying the results of their reported test results with the following information:
This test has
not been reviewed by the FDA.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the
Follow-up testing with a moleculardiagnostic should be considered to rule out infection in these individuals.
Results from antibody testing
should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
Positive results may be due
to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
The FDA specifically
notes in its emergency use FAQ that these entities have reported their own validation of these tests, and that they won''t be pursuing
Emergency Use Authorization
That said, there now nothing stopping the entities on this list from distributing their tests, which means they will be able to be put to
use in testing Americans and painting a larger picture of the potential spread of the novel coronavirus — with the caveat noted above that
the FDA doesn''t consider these tests used alone to be positive confirmation of a definite SARS-CoV-2 case, or conversely, a sure indicator
that someone doesn''t have the virus.
Still, in the absence of better options like expanded availability of the tests that are approved
under the EUA, these serological tests (many of which can provide on-site results with just a pinprick of blood) will be useful in painting
a more accurate picture of the overall spread and reach of the coronavirus, especially for smaller clinics, GP clinics and local labs that
don''t have priority access to the equipment and supplies needed for the molecular testing efforts.
For instance, one test on this list, the
Healgen Scientific COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device, requires no instrumentation and can provide results in
Distributor Ideal Rehab Care is working with its legal representation Fox Rothschild to begin importing the tests from Singapore for use &as
soon as possible.
The FDA updating its website with Healgen as one of the entities that have notified it of intent to use its serological
test is what unlocked the ability for the company to begin distribution: It still illegal for anyone not on this list to do so, and the FDA
still also specifically prohibits the use of at-home serological tests on its official guidelines.
