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FDA Approves Emergency Use Authorization for a 24-hour, Saliva Test for COVID-19 –

FDA Approves Emergency Use Authorization for a 24-hour, Saliva Test for COVID-19

What You Should Know:

The FDA has provided Emergency Use Authorization for a 24-hour, Saliva Test for COVID-19, available now to clinics, hospitals, and patients.

– In light of recent complications with and warnings for new tests, here is a quick list of information on the validated test and how it is different from existing testing and other alternatives in development: 

– The saliva-based test for COVID-19 has been validated and proven as a consistent sample method.


– FDA Resource-Designated Laboratory, MicroGenDX is ramping up capacity for 10,000 tests/day with a turnaround time of 24 hours.


MicroGenDX
Laboratories
, the world leader in providing PCR and Next Generation DNA
Sequencing in microbial identification, has validated a real-time Reverse
Transcriptase PCR (rRT-PCR) assay for the specific detection of the SARS- CoV-2
virus. MicroGenDX laboratory is
the first national laboratory to offer validated COVID-19 testing using saliva
and sputum samples. The validation summary that exceeds the requirements of the
FDA Emergency Use Authorization. Additionally, the test has been validated for
both Nasopharyngeal (nasal) and Oropharyngeal (oral) swabs.

As indicated in a 2020
JAMA Study of Clinical Sputum Specimens for COVID
, patients may have higher
viral shedding patterns at different collection sites, with sputum collection
being the most consistent sample method after bronchoalveolar lavage. While
other laboratories and tests rely on nasal and throat swabs, MicroGenDX
designed their COVID-19 collection method around sputum to more accurately
identify the SARS- CoV-2 virus. 

MicroGenDX planned the collection technique around saliva
and sputum to prevent reliance on supply materials currently in shortage such
as swabs and Viral Transport Media. The laboratory’s solution to the latter was
to validate sterile saline as a viable transport media for testing. 

“Our goal is to remove as many hurdles from people getting
answers about COVID- 19,” continues Martin. “Given the challenges the
healthcare system is having with procuring both swabs and transport media, we
wanted to have another option for the healthcare provider to test
patients.” 

MicroGenDX runs its COVID-19 Rapid PCR Test at its
diagnostic laboratory in Lubbock Texas with a 24-hour turnaround from time of
sample receipt. The laboratory has begun running tests at a capacity of
5,000 COVID-19 samples a day and plans to increase that number to 10,000 per
day in the near future. 

MicroGenDX accepts samples from every state, joining the
national response to COVID-19 at a time when hospital systems and drive-up
testing facilities are hitting capacity and struggling to keep up with
ever-increasing demand. The laboratory is currently bolstering its existing
diagnostic teams to scale testing in accordance with the growing public
need. 

MicroGenDX is listed on the FDA Website as a resource
laboratory for COVID-19 Testing as “Southwest Regional PCR dba MicroGenDX
Laboratory.” 

FDA Emergency Use Authorization Information

– In reporting information about this test, please be advised of the following:

– This test has been authorized by FDA under an EUA for use by authorized
Laboratories. This test has not been FDA cleared or approved.

– This test has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens.

– This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for.

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