A lateral flow immunoassay designed for the qualitative detection of IgG and IgM antibodies to the SARS-CoV-2 virus in the whole blood, serum or plasma specimens from individuals suspected of COVID-19 infection by their healthcare provider.
- For In Vitro Diagnostic Use only.
- For healthcare professionals and professionals at point of care sites.
- Do not use after expiration date.
- Please read all the information in this leaflet before performing the test.
- The test cassette should remain in the sealed pouch until use.
- All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
- The used test cassette should be discarded according to federal, state and local regulations.
1. The test can be used to test whole blood (venipuncture blood and capillary finger prick blood) /serum / plasma (EDTA, Heparin , Citrate) specimens.
2. To collect whole blood serum or plasma specimens following regular clinical laboratory procedures.
3. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.
4. Store specimens at 2-8°C (36-46°F) if not tested immediately. Store serum/ plasma/ anticoagulated venipuncture whole blood specimens at 2-8°C for up to 3 days. The serum/plasma especimens should frozen at -20°C (-4°F) for longer storage. Do not freeze whole blood specimens.
5. Fresh fingerstick blood specimens should be collected and tested immediately.
6. Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.
7. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.
Allow the test device and specimens to equilibrate to temperature (15-30°C or 59-86°F) prior to testing.
1. Remove the cassette from the sealed pouch.
2. Hold the dropper vertically and transfer 1 drop (approximately 10ul) of specimen into the front of the specimen well(S) making sure that there are no air bubbles. For better precision, transfer specimen by a pipette capable of delivering 10ul of volume.
3. Then, add 2 drops (approximately 70ul) of buffer immediately into the specimen well (S)
4. Start timer.
5. Wait for colored lines to appear. Interpret the test results at 15 times. DO NOT READ RESULTS AFTER 20 MINUTES.