Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.
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Advanced Diagnostic Technology
- Lateral Flow Test – suitable for rapid, on-site testing
- Performance: sensitivity of 94.70% (125/132) and specificity of 98.89% (268/271).
- The test has been clinically validated during the 2020 COVID-19 outbreak in China
- Easy-to-use: No special equipment. Works with whole blood, serum or plasma samples
- Fast: clear answer within only 15 minutes