When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgM anti-Novel coronavirus, if present in the specimen, will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent pre-coated on the IgM band, forming a burgundy colored IgM line, indicating a Novel coronavirus IgM positive test result.
Allow the test device and specimens toequilibrate to temperature (15-30 °C or 59-86°F) prior to testing
1.Remove the test cassette from the sealed pouch.
2.Hold the dropper vertically and transfer 1 drop of specimen (approximately 10^l) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 70^l) and start the timer. See the illustration below.
3.Wait for colored lines to appear. Interpret the test results in 15 minutes. Do not read results after 20 minutes.
This test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose exclude SARS-CoV-2 infection or to inform infection status.