SARS-CoV-2 lgM ELISA

The Wantai SARS-CoV-2 lgM ELISA from Beijing Wantai Biological Pharmacy qualitatively detects lgM-class antibodies to SARS-CoV-2 in human serum and plasma. This enzyme-linked immunosorbent assay is for the testing of patients suspected of recent infection with the SARS-CoV-2 virus.

Performance evaluations
• Medizinische Universität Wien
Medizinische Universität Wien in Austria reported a kit sensitivity of 92% (6 ~10 days) to 100% after day 11 post disease onset and a specificity of 97%.
Medizinische Universität Wien article
• Dutch Serology Taskforce
In the Netherlands, data collection and reporting by the Dutch Serology Taskforce, part of the Dutch National Testing Capacity Coordination Structure, showed kit sensitivity of 91.9% for samples collected >14 days after the onset of illness
Dutch Serology Taskforce report

UK Government COVID-19 testing guidance
The UK Government’s guidance regarding the use of the COVID-19 diagnostic assays can be found here

The test should not be used as the sole basis for diagnosis.