This kit is suitable for the qualitative detection of novel coronavirus (SARS-CoV-2) IgG antibodies in human serum, plasma, and whole blood. The detection kit uses the principle of immunochromatography: the separation of components in a mixture through a medium using capillary force and the speciﬁc and rapid binding of an antibody to its antigen.
• Negative: If only the control line (C) appears and the test line (T) is not visible, then no novel coronavirus antibody has been detected.
• Positive: If both the control line (C) and the detection line (T) appear, then the novel coronavirus antibodies have been detected and the result is positive.
• Suspect: A light pink band is an inconclusive result. The sample requires an alternate testing method (such as RT-qPCR) to determine that the result is positive.
• Invalid: No visible colored bands appear at control line after performing the test. The directions may not have been followed correctly or the test may have deteriorated. It is recommended to re-test the specimen.
- This kit is only provided for use for point-of-care testing, and not for at home testing by clinical laboratories or to healthcare workers in a facility or a laboratory with a CLIA certification to perform high complexity tests.
- This kit is designed to detect antibodies against SARS-CoV-2 in human whole blood, serum sample.
- This product is for in vitro diagnostic use only. It follows guidance from the FDA for Emergency Use Authorizations of tests submitted on March 16, 2020.
BB Rapid-MT Coronavirus IgG/IgM Antibody Test Kits (20 tests/1 box)
20 IgG/IgM pouches each containing:
1 combined test cassette
1 disposable pipette
1 desiccant pouch
20 dilution buffer tubes
20 disposable lancets
Instructions for use