Wantai SARS-CoV-2 lgM ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of lgM-class antibodies to SARS-CoV-19 virus in human serum or plasma. It is intended for testing of patients suspected of recent infection with the SARS-CoV-2 virus. The test should not be used as the sole basis for diagnosis. The test is based on antibody-capture method.
Performance evaluations (click on the links to open each study report)
The Medizinische Universität Wien in Austria reported sensitivity of 92% (6 ~10days) to 100% after day 11 post disease onset, and 97% specificity of the kit. In the Netherlands, data collection and reporting by the Serology Taskforce, which is part of the Dutch National Testing Capacity Coordination Structure shows sensitivity of the kit of 91.9% for samples collected > 14 days after onset of illness.