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.