Our Response to COVID-19

As the COVID-19 pandemic unfolded, Brevitest recognized early on that its point-of-care diagnostic platform could play a meaningful role in curbing the health crisis by providing easy to use diagnostics that can widely deployed.

We have developed a first-in-class diagnostic test for virus-specific IgG in blood and IgA in saliva. 
The IgG serology test is now authorized for commercial distribution by the FDA*.
The IgA saliva serology test is currently under review for an emergency use authorization (EUA) at the FDA.

We continue to work on development of other diagnostic tests to combat the pandemic. Check back for more updates.

A HIGH QUALITY SEROLOGY TEST FOR COVID-19

Brevitest SARS-CoV-2 IgG Test

The Brevitest SARS-CoV-2 IgG Test is a high quality enzyme-linked immunoassay which detects the presence of IgG antibodies to the SARS-CoV-2 virus in human serum or plasma. The presence of these antibodies indicate prior exposure to the virus, and can be an indicator of immunity to future COVID-19 disease. IgG antibody is typically detected in the serum/plasma of patients after 7 days of being infected. It stays in the blood for a longer time than other antibodies, although the duration of time is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

The Brevitest SARS-CoV-2 IgG Test showed sensitive and specific detection of the antibodies in a clinical study using patient samples:

  • Validated using 111 patient samples (33 positive, 78 negative)
  • Test sensitivity: 100%
  • Test specificity: 100%

The test is fast and easy:

  • Sample: 3µl of sample (serum/plasma) needed
  • Test run time on Acuity™ analyzer: about 10 minutes

This test is now permitted for commercial distribution by the FDA*. For more details click below:

*This test has not been FDA cleared or approved. The commercial distribution of this test is permitted by FDA under Section IV.D of their March 16 2020 Guidance on “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency”. This test has been validated only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only permitted for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary by country and is subject to regulatory requirements.

The Brevitest Acuity™ analyzer

  • The Brevitest Acuity™ analyzer is a small, tabletop device that runs Brevitest immunoassays.
  • The analyzer does not require any inputs beyond accepting the test cartridge. It performs an entire laboratory-quality ELISA test on the test cartridge. At the end, the test data is uploaded to the cloud and the analyzer is ready to run the next test.

A Painless way to test for COVID-19

Brevitest IgA Saliva Serology Test for SARS-CoV-2

The Brevitest IgA Saliva Serology Test for SARS-CoV-2** is an enzyme-linked immunoassay intended for the qualitative detection of IgA antibodies to SARS-CoV-2 in human saliva. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

The test is designed to be simple to administer and quick to run on Brevitest’s proprietary Acuity™ analyzers, with very little sample preparation.

**The IgA saliva serology test is currently under review for an emergency use authorization (EUA) at the FDA. The test is not currently available for sale.

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