Auxiliary test for the detection of corona virus (COVID-19) antibodies
Easy to use, instant result in 15 minutes.
This kit is suitable for the qualitative detection of novel coronavirus (SARS-CoV-2) IgM & 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.
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.
It is well established that the initial defense to a foreign antigen involves a complex immune response, both innate and adaptive types. Antibody response in the form of IgM provides a critical defense during early stages of viral infections. Subsequent development of a longer-term IgG antibody further augments the adaptive immune response and may eventually lead to some form of immunological memory. Testing of COVID-19 IgM and IgG antibodies therefore, is an effective method for early detection of humoral response to COVID-19 infection and of diagnostic value. Whereas viral presence may wane subsequently, antibody response will be rising, especially from the second week onwards, allowing for greater assessment of SARS-CoV-2 infection and exposure. As such, serological antibody testing can be of signiﬁcant point-of-care COVID-19 assessment method.
Coronavirus (SARS-CoV-2) Test kit (Lateral flow method)
Study on 596 patients
Sensitivity: 86.43% (95%CI: 82.41%-89.58%)
Specificity: 99.57% (95%CI: 97.63%-99.92%)
Total consistent: 91.61% (95%CI: 89.10%-93.58%)
20 individual pouches, each containing:
1 Test cassette
1 Desiccant pouch
20 disposable droppers
Detection buffer (1* 6 mL)
Instructions for use
This kit is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.
This kit is designed to detect antibodies against SARS-CoV-2 in human whole blood, serum sample.
This test has not been reviewed by the FDA.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
Not for the screening of donated blood.
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.