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Xiamen Wiz Biotech Rapid Coronavirus Immunoassay Kit Gets CE Mark

NEW YORK — Xiamen Wiz Biotech has received CE marking for its SARS-CoV-2 rapid antibody-detection kit.

The qualitative membrane-based immunoassay is designed to detect immunoglobulin G and M antibodies against the virus in whole blood, serum, and plasma, according to the Xiamen, China-based company.

During testing, SARS-CoV-2 antigen-coated particles on a test strip bind to anti-SARS-CoV-2 IgG or IgM in the sample. The binding complexes then migrate up the membrane, driven by capillary forces, and the antibodies are detected by anti-human IgG and IgM antibodies on the test strip. The kit does not require any additional equipment and results are available in 10 to 15 minutes. In clinical testing against samples with confirmed clinical diagnoses, the test demonstrated 92.1 percent sensitivity and 97.9 percent specificity.

The kit is being distributed by Hong Kong-based GLLC-Medical.