SARS-CoV-2 IgG/IgM Rapid Test Kit
Intended Use: To detect IgM and IgG antibodies against N and S protein of SARS-CoV-2 in whole blood, serum and plasma
Product Format: 25 tests/kit
Kit Contents: test card, diluent, capillary, lancet, and instruction for use.
Storage/Stability: 2 C to 30C for 12 months.� eproducibility /Precision
100% Concordant across 3 lots with CV ±5%
Performance Comparison (A)
China Validation Test
Positive Samples 100 / 102
Sensitivity: 98.04%
Negative Samples 491/492
Specificity: 99.80%
Overall Accuracy: 99.49%
Performance Comparison (B)
Positive Samples 23 / 25
Sensitivity: 92%
Negative Samples 25 / 25
Specificity: 100%
Overall Accuracy: 96%