The COVID-19 IgG / IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-nCoV-19 IgG virus and anti-nCoV-19 IgM virus in human whole blood, serum or plasma . It is intended for use by professionals as a screening test and as an aid in the diagnosis of infection with nCoV-19 viruses. Any sample reactive with the COVID-19 IgG / IgM rapid test should be confirmed by alternative test methods.
Cross-reactivity was 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 taken from selected subjects, all samples were tested with the ACtest COVID-19 IgG / IgM rapid test cassette and by a standard PCR method. Calculation of specificity and sensitivity based on the overall test results 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%).
