The Crossection
  • Home
  • CroSS Consulting
  • CroSS Topics
    • CroSS Blog
  • P of the F
    • P of the F Blog
  • Author Info
  • Contact

COVID-19 Testing Update

4/5/2020

0 Comments

 
Picture
In the United States, medications and tests utilized to asses medical conditions may only be introduced into the stream of commerce once they pass numerous, stringent requirements. However, when a public health emergency surfaces that could be managed effectively with products and therapies not yet approved, provisions in the law permit the FDA to fast track biologics, diagnostic tools and other medical equipment.

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined that COVID-19 posed a public heath emergency to U.S. citizens. By declaring this public health emergency, the Secretary of HHS triggered section 564(b)(1)(C) of the Federal Food, Drug and Cosmetic Act. In accordance with this provision, the FDA Commissioner may allow unapproved medical products, or unapproved uses of approved medical products, to be used to test for or to treat the life-threatening disease causing the health crisis. For each item approved to assess, treat or protect against COVID-19 during this time period, an Emergency Use Authorization (EUA) is issued.

To date, the following EUAs have been issued:

MEDICATIONS
March 28, 2020
  • Approval to use chloroquine and hydroxycholoroquine for off-label use to treat COVID-19.

DIAGNOSTICS
February 4, 2020
  • CDC’s use of COVID-19 real time reverse transcriptase (RT)-PCR diagnostic evaluation from upper and lower respiratory tract samples (qualitative detection of nucleic acid).
February 29, 2020
  • New York State Department of Health’s use of COVID-19 RT-PCR nasal and oral swab test (qualitative detection of nucleic acid from sample).
March 12, 2020
  • Roche Molecular System’s COVID-19 nasal and oral swab test (qualitative detection of nucleic acid from sample).
March 13, 2020
  • Thermo-Fisher Scientific’s COVID-19 nasal swab and broncho-alveolar wash test (qualitative detection of nucleic acid from sample).
March 16, 2020
  • Hologic’s Panther Fusion COVID-19 nasal and oral swab test (qualitative detection of nucleic acid from sample).
  • Laboratory Corporation of America’s COVID-19 RT-PCR test using upper and lower respiratory tract samples (qualitative detection of nucleic acid).
March 17, 2020
  • Quidel Corp.’s Lyra SARS CoV-2 Assay test using nasal and oral samples (qualitative detection of nucleic acid).
  • Quest SARS CoV-2 rRT-PCR test using upper and lower respiratory tract samples (qualitative detection of nucleic acid).
March 18, 2020
  • Abbott Molecular’s RealTime SARS CoV-2 assay test using nasal and oral samples (qualitative detection of nucleic acid).
March 19, 2020
  • DiaSorin Molecular’s Simplexa COVID-19 Direct test using nasal samples (qualitative detection of nucleic acid).
  • GenMark Diagnostic’s ePlex SARS CoV-2 Test using nasal samples (qualitative detection of nucleic acid).
March 20, 2020
  • ·Primerdesign’s COVI9-19 genesig Real-Time PCR assay using oral samples (qualitative detection of nucleic acid).
  • Cepheid’s Xpert Xpress SARS CoV-2 test using nasal samples (qualitative detection of nucleic acid). ** Can be performed outside of a laboratory in a patient care setting**
March 23, 2020
  • BioFire Defense’s BioFire COVID-19 Test using nasal samples (qualitative detection of nucleic acid).
  • Mesa Biotech’s Accula SARS CoV-19 Test using nasal and oral samples (qualitative detection of nucleic acid). **Can be performed outside of a laboratory in a patient care setting.**
March 24, 2020
  • PerkinElmer’s PerkinElmer New Coronavirus Nucleic Acid Detection Kit using nasal and oral samples (qualitative detection of nucleic acid).
March 25, 2020
  • Avellino Lab’s AvellinoCoV2 test using nasal and oral samples (qualitative detection of nucleic acid).
March 26, 2020
  • BCI Genomics’s Real-Time Florescent RT-PCR Kit for Detecting SARS-2019-nCoV using oral samples and bronchiole-alveolar wash test (qualitative detection of nucleic acid from sample).
  • Abbott Diagnostic Scarborough’s ID NOW COVID-19 test, using oral and nasal samples (qualitative detection of nucleic acid). **Can be performed outside of a laboratory in a patient care setting.**
March 27, 2020
  • Luminex Molecular Diagnostics Nx TAG CoV Extended Panel Assay test using nasal swabs (qualitative detection of nucleic acid).
March 30, 2020
  • NeuMoDx Molecular’s NeuMoDx SARS-CoV-2 Assay test using nasal and oral samples (qualitative detection of nucleic acid).
  • QIAGEN GmbH’s QIAstat-Dx Respiratory SARS CoV-2 Panel test using nasal samples (qualitative detection of nucleic acid).
April 1, 2020
  • Cellex, Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test to detect IgG and IgM antibodies against SARS CoV-2 in whole blood, serum or plasma. **Antibody Test**
  • Ipsum Diagnostics’s COV-19x Assay test using nasal and oral samples (qualitative detection of nucleic acid).
April 2, 2020
  • Becton, Dickinson & Company’s BioGX SARS-CoV-2 Reagents for BD MAX System using nasal and oral samples (qualitative detection of nucleic acid).
April 3, 2020
  • Luminex Corporation’s ARIES SARS-CoV-2 Assay using nasal swabs (qualitative detection of nucleic acid).
  • ScienCell Research Laboratory’s SARS-CoV-2 Coronavirus Real-time RT-PCR Detection Kit using nasal, oral and bronchi-alveolar wash (qualitative detection of nucleic acid).
  • Co-Diagnostics’s Logix Smart Coronavirus Disease 2019 (COVID-19) kit using nasal, oral and bronchi-alveolar wash (qualitative detection of nucleic acid).

In the above list, 27 products have been approved to provide a qualitative assessment of COVID-19 in the upper and/or lower airway. Three of those products can be performed at the location where the patient is being tested. One additional product has been approved to test for antibodies in whole blood, serum or plasma.

Normally, it takes months or years to have a new test approved or to have a medication approved for off-label use. Under this circumstance, the speed with which these tests was developed is truly remarkable. Also, national testing will certainly be accomplished more rapidly as a result of the FDA’s issuance of these EUAs.

If you know someone who is exhibiting signs, tell that person to do a search for testing locations in or around their communities. As the number of companies approved to manufacture tests increases, the number of available tests will increase, and commensurately, the number of testing sites will increase. Early detection can help manage the virus.


QUESTIONS YOU MAY HAVE
  1. What is the difference between qualitative and quantitative? Qualitative studies reveal the presence or absence of what is being assessed. Quantitative studies assess how much of the item being studied is present in the sample taken. For COVID-19, clinicians need to know if you are positive or negative for the virus, which is why the approved tests all seek qualitative results.
  2. Why are the tests designed to identify nucleic acid? Nucleic acid is generally detectable in the respiratory pathway (nose and oral cavity) during the acute phase of the COVID-19 infection.

Below is a link to the FDA website listing all EUAs issued to date in response to COVID-19:
​ https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov

0 Comments



Leave a Reply.

    M. Regina

    Before entering law school in my 30's, I worked as a NYC paramedic and a high school biology teacher. Now a mom, wife and litigator, my goal is to use my skills to help others.

    Archives

    April 2020
    March 2020

Home

Cross Blog

P OF THE F

Contact

Copyright © 2020
  • Home
  • CroSS Consulting
  • CroSS Topics
    • CroSS Blog
  • P of the F
    • P of the F Blog
  • Author Info
  • Contact