FlexImmArray™ SARS-CoV-2 Human IgG Antibody Test
Extensively validated as per FDA guidelines
Instructions for use• Notified FDA about test validation. The Tetracore FlexImmArray™ test is listed on the FDA website.
• As stated in section IV.D of the FDA’s Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer’s development and distribution of serology tests to identify antibodies to SARS-CoV-2.
• EUA application submitted to FDA on May 26, 2020
• Assay validation technical details
The Tetracore FlexImmArray™ SARS-CoV-2 Human IgG Antibody Test is a multiplex test for the detection of human IgG antibodies, in plasma and serum samples, against the virus that causes COVID-19. The test results, along with other clinical and diagnostic information, can help a health care provider make informed recommendations for the care of a current or recovering patient.
This multiplex test utilizes multiple antigens from the virus and provides a very high specificity to the assay. The FlexImmArray™ SARS-CoV-2 Human IgG Antibody Test also includes four internal controls in every well to assure the high performance of the assay. The high specificity of antibody testing is vital for a reliable determination of exposure to the virus.
Each test kit includes reagents and plates for testing 90 samples. The time to first result is about 1 hour. The high specificity and rapid turnaround time of this test enable laboratory testing of a high number of samples in a short period.