The COVID19 Ab test is for in vitro diagnostic use only. This test should be used for the detection of IgG and IgM antibody to SARS-CoV-2 in whole blood, serum or plasma specimens. Neither the quantitative value nor the rate of increase in the concentration of IgG or IgM antibodies to SARS- CoV-2 can be determined by this qualitative test.

The COVID19 Ab test will only indicate the presence of IgG and IgM antibodies to the SARS-CoV-2 virus in the specimen and should NOT be used as the sole criteria for the diagnosis of COVID19infections.

A negative result for an individual subject indicates the absence of detectable anti-COVID-19 antibodies. However, a negative test result does not preclude the possibility of exposure to or infection with COVID-19. A negative result can occur if the quantity of the anti-COVID-19 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.

The hematocrit level of the whole blood can affect the test results. Hematocrit level needs to be between 25% and 65% for accurate results.

As with all diagnostic tests, all results must be considered with other clinical information available to the physician.