SARS-CoV-2 Ab ELISA can detect total antibodies to indicate the immune response of patients suspected of previous SARS-CoV-2 infection to SARS-CoV-2, or to detect known recent SARS-CoV-2 infections . The test can also be used with other tests and clinical information to assist in the diagnosis of acute or past SARS-CoV-2 infection. When interpreting positive test results, the prevalence of SARS-CoV-2 infection in the area where the test occurred should be considered. This test should not be used as the sole basis for diagnosis.
The kit can detect total antibodies (IgG, IgM and IgA) against S-RBD, and has been extensively evaluated and validated in Europe.
In the Netherlands, a report from the Dutch Serological Task Force showed that the kit has a sensitivity of 98.1% for samples collected more than 14 days after the onset of illness. The report of the Dutch Serological Task Force can be downloaded from HERE. In other studies conducted in the Netherlands, the sensitivity of Erasmus Medical Center was 98% (100 days> 14 days), the PPV calculated by the Sanquin blood bank was 99%, 88%, and 72%, respectively, and the prevalence rate was 4 -10%, 2-4%, <2%. .
The Stanton Serum Institute in Denmark showed a sensitivity of 71% (7-13 days) to 100% (10 days). Also in Denmark, a multi-center comparative study ranked Wantai SARS-CoV-2 Ab ELISA as the highest serological test among the 15 commercially evaluated tests (including automated immunoassays). The MedizinischeUniversität University Vienna calculated 92~100% sensitivity in Austria, and evaluated the kit in France, the French National Reference Center (CNR), and concluded that it has (100% (7-13days), 95% sensitivity (14-19days) and 98% (>20 days). A study conducted by the University Hospital of Padova in Italy showed that the consistency with the automated immunoassay method exceeded 98%. In Belgium, the AZ Delta Medical Laboratory and Ghent University concluded that the Wantai SARS-COV-2 Ab ELISA is suitable for sensitive and specific screening for SARS-CoV-2 infection from 10 days after the onset of symptoms. The ICMR/NIV of India evaluated the kit with a sensitivity of 98% and a specificity of 100%.
In the United States, a validation study conducted by the National Cancer Institute (NCI) showed that the sensitivity of the test was 96.7% (29/30) and the specificity was 97.5% (78/80). Subsequently, WANTAI SARS-CoV-2 Ab ELISA received FDA emergency use authorization on August 5, 2020.