Principle of Rapcov™ COVID-19 Rapid Test
Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection, like COVID-19. In other words, the test detects the body’s immune response to the infection caused by the virus rather than detecting the virus itself. In the early days of an infection when the body’s immune response is still building, antibodies may not be detected. This limits the test’s effectiveness for diagnosing COVID-19 and why it should not be used as the sole basis to diagnose COVID-19.
Serological tests can play a critical role in the fight against COVID-19 by helping healthcare professionals to identify individuals who have overcome an infection in the past and have developed an immune response. In the future, this may potentially be used to help determine, together with other clinical data, that such individuals are no longer susceptible to infection and can return to work. In addition, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19.
Rapcov™ COVID-19 Rapid Test is a lateral flow immunochromatographic assay intended for the presumptive qualitative detection of IgG or IgM antibodies to the 2019-nCoV in fingerstick whole blood from individuals who are suspected of COVID-19 virus exposure. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform moderate and high complexity tests.
When present in the patient sample, COVID-19 specific IgM or IgG antibodies bind to anti-human IgM or IgG antibodies immobilized in two lines across the RapCov cassette membrane. Colloidal gold complexes containing recombinant COVID-19 nucleocapsid antigens are captured by the patient’s IgM or IgG antibodies to give visible pink line(s). A procedural control is included to indicate that the assay has been performed correctly and is valid. The RapCov test does not produce an actual test report. The testing laboratory or health care workers at point-of-care must include the test result information in their report.
Negative results on Rapcov™ COVID-19 Rapid Test do not preclude 2019-nCoV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Positive results are presumptive and must be confirmed by viral nucleic acid detection by RT-PCR for confirmation of COVID-19 virus infection. Positive results may be due to past or present infection with non-COVID-19 virus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
The RapCov™test results can be useful for the presumptive differentiation between recent and past infection. Results from antibody testing should not be used as the sole basis to diagnose or exclude COVID-19 virus infection or to inform infection status. The Rapcov™ COVID-19 Rapid Test is intended for use by healthcare providers. The Rapcov™ COVID-19 Rapid Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.