SARS-CoV-2 antibody rapid test
Rapid detection of complete antibodies for SARS-CoV-2 antibodies
! ! ! Important note: This product is only for professional use and cannot be used for self-inspection or testing at home!
The WANTAI SARS-CoV-2 Ab rapid test is a 15-minute test that can detect total antibodies in patients suspected of previous SARS-CoV-2 infection to indicate an immune response to SARS-CoV-2 or subsequent serum Transformation detects patients with the most recently known SARS-CoV-2 infection. The kit is based on the dual antigen "sandwich" method, which can detect total antibodies against S-RBD. 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 SARS-CoV-2 infection rate in the area where the test occurred should be considered. This test should not be used as the sole basis for diagnosis.
In limited validation, the RIVM National Institute of Public Health of the Netherlands and the Ministry of Health of the Czech Republic both reported that its sensitivity and specificity were both 100%. In Austria, the sensitivity calculated by the Medical University of Vienna is 80% (6-10 days) and 100% (>11 days), and the sensitivity reported by the University of Innsbruck is 95.7% (100%>14 days), and the specificity is 100%. In France, the French National Reference Center (CNR) evaluated the kit and concluded that the sensitivity of the kit was 89% (7-13 days), 92% (14-19 days) and 94% (>20 days).
In the United States, a validation study conducted by the National Cancer Institute (NCI) showed that the sensitivity of the test is 100% (30/30) and the specificity is 98.8% (79/80). Subsequently, WANTAI SARS-CoV-2 Ab rapid test was granted FDA emergency use authorization on July 10, 2020