COVID-19 rapid test AB ELISA

IgAIgGIgM

WANTAI SARS-CoV-2 Ab ELISA detects total antibody as indicative of an immune response to SARS-CoV-2 in patients suspected of previous SARS-CoV-2 infection, or for the detection of seroconversion in patients following known recent SARS-CoV-2 infection. The test may also be used to aid in the diagnosis of acute or past SARS-CoV-2 infection in conjunction with other tests and clinical information. The prevalence of SARS-CoV-2 infection in the area where testing has occurred should be considered when interpreting positive test results. The test should not be used as the sole basis for diagnosis. Performance evaluations (click on the links to open each study report) The kit detects TOTAL ANTIBODIES (IgG, IgM and IgA) against S-RBD and it has been extensively evaluated and validated in Europe. In the Netherlands, reporting by the Dutch Serology Taskforces shows sensitivity of the kit of 98.1% for samples collected > 14 days after onset of illness, the Dutch Serology Taskforce report can be downloaded from HERE. In other studies conducted in the Netherlands, Erasmus Medical Center showed sensitivity of 98% (100% >14days) and Sanquin Blood Bank calculated PPV of 99%, 88%, and 72% in areas with prevalence of 4-10%, 2-4%, and <2%. . Statens Serum Institut in Denmark showed sensitivity of 71% (7~13days) ~ 100% (10days) . Also in Denmark, multicentre comparison study ranked Wantai SARS-CoV-2 Ab ELISA as the top serology assay among 15 commercially evaluated tests including automated immunoassays.