Intended Use:The One Step SARS-CoV2(COVID-19)IgG/IgM Test is a rapid chromatographic immunoassay
for the qualitative detection of antibodies (IgG and IgM) to COVID-19 virus in Whole Blood
/Serum / Plasma to aid in the diagnosis of COVID-19 viral infection.
Test Procedure:Allow the test, specimen, buffer and/or controls to reach room temperature 15-30 (59-86)
prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the
sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. Hold the dropper vertically and transfer 1 drop of specimen (approximately 10l) to the
specimen well(S) of the test device, then add 2 drops of buffer (approximately 70l) and
start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the
result after 20 minutes.
Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting
of membrane) is not observed in the test window after one minute, add one more drop of buffer
to the specimen well.