BTNX Rapid Response COVID-19 Test Cassettes
The Rapid Response COVID-19 Test Cassette is a rapid, qualitative test for the detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasm samples, to aid in the diagnosis of COVID-19. Interpretation of test results are COVID-19 virus positive (two lines or three lines) and COVID-19 virus negative (one line). Available for research use only. CE mark and Health Canada approval pending for diagnostic use.
NOTES FOR CLINICAL USE IN THE UNITED STATES:
On March 16, 2020 the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The updated policy can be viewed at https://www.fda.gov/media/135659/download.
This test is for professional in vitro diagnostic use only. Read the product insert prior to use. Directions should be read and followed carefully.