The ACtest COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–nCoV-19 virus and IgM anti-nCoV-19 virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with nCoV-19 viruses. Any reactive specimen with the COVID-19 IgG/IgM Rapid Test must be confirmed with alternative testing method(s).
Cross-reactivity has been evaluated against OC43 antibody, HIV antibody, HBsAb, HCV antibody, Treponema pallidum antibody, Mycoplasma pneumonia antibody, and Helicobacter pylori antibody. No cross-reactivity was observed during the test.
523 samples were collected from selected subjects, all samples were tested with ACtest COVID-19 IgG/IgM Rapid Test Cassette and by a reference PCR method. Calculated the specificity and sensitivity based on the overall test results of which regardless of IgM positive or IgG positive, Relative Sensitivity: 90.9% (84.9%~95%), Relative Specificity: 100% (99%~100%), Overall Agreement: 97.5% (95.8%~98.7%).
