Rapid Test for Total Antibody to SARS-CoV-2
IMPORTANT: THIS PRODUCT IS INTENDED FOR PROFESSIONAL USE ONLY, NOT FOR SELF-TESTING OR TESTING AT HOME!
WANTAI SARS-CoV-2 Ab Rapid Test is a 15minutes test that 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 kit is based on double antigen "sandwich" method and it detects TOTAL ANTIBODIES against S-RBD. 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):
In a limited validations, the RIVM National Institute for Public Health in the Netherlands, and the Ministry of Health in the Czech Republic both reported sensitivity and specificity of 100%. In Austria, the Medizinische Universität Wien calculated sensitivity of 80% (6-10days) and 100% (>11days) respectively, and the University of Innsbruck reported sensitivity of 95.7% (100% >14days) and specificity of 100%. In France, the French National Reference Center (CNR) evaluated the kit and conclude that it has sensitivity of 89% (7-13days), 92% (14-19days) and 94% (>20days) respectively.
In the United States, validation study conducted by the National Cancer Institute (NCI) showed sensitivity of 100% (30/30) and specificity of 98.8% (79/80) of the test. Subsequently, WANTAI SARS-CoV-2 Ab Rapid Test received FDA Emergency Use Authorization on July.10,2020. Downloads: Letter of Authorization , HCP , Recipients , IFU , NCI Report.
FIND evaluation results are expected soon.