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%
