How is the COVID-19 Rapid Test Composed?
The test strip consists of a sample pad and a chromatographic membrane (the detection area is coated with a mouse anti-human IgM monoclonal antibody and a mouse anti-human IgG monoclonal antibody and goat anti-mouse IgG antibody), colloidal gold binding pad (coated with colloidal gold-labeled recombinant novel coronavirus (COVID-19) antigen and mouse lgG antibody), liner and absorbent pad.
What Influences the testing results?
Please make sure the kit is recovered into room temperature and perform the kit under the room temperature(15℃~30℃). The results will be affected by high or low temperature.
What are the sample requirements?
Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingertip should be tested immediately.
How accurate is the COVID-19 Rapid Test?
In order to test the detection sensitivity and specificity of the COVID-19 IgG-IgM combined antibody test, blood samples were collected from COVID-19 patients from multiple hospitals and Chinese CDC laboratories. The tests were done separately at each site. A total of 615 cases were tested: 403 (positive) clinically confirmed (including PCR test) COVID-19-infected patients and 212 non- COVID-19-infected patients (212 negative). The testing results of vein blood without viral inactivation were summarized in the Table 1. Of the 403 blood sample from COVID-19-infected patients, 397 tested positive, resulting in a sensitivity of 98.511%. 25 of the blood samples from the 212 non-COVID-19 infection patients tested positive, generating a specificity of 88.208%.
What are the alternatives?
The COVID-19 IgM/IgG Rapid Test can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.