1. Negative coincidence rate: the reference for testing negative enterprises (N1-N10), 10 copies shall be negative.
2. Positive coincidence rate: the reference for positive enterprises (P1-P10), P1-P4 should be IgM positive and IgG positive, P5-P7 should be IgM positive and IgG negative, P8-P10 should be IgM negative and IgG positive.
3. Minimum test limitation: test the enterprise sensitivity reference S1~S4(diluted by the enterprise sensitivity reference S in accordance with 1:32, 1:64, 1:256 and 1:512). It is required that S1 and S2 should be positive for IgM and IgG, while S3 and S4 should be negative.
4. Batch repeatability: use the same batch kits to test negative enterprise repetitive reference products C1 and repetitive positive reference C2 (IgM and IgG are all positive) respectively. Each sample was tested 5 times in parallel, where C1 test results should be negative and C line color is consistent, and C2 test results should be IgM positive and IgG positive with consistent color
5. Inter-batch repeatability: three consecutive batch number kits were used to test the enterprise's repeatable negative reference C1 and repeatable positive reference C2(both IgM and IgG were positive), and each sample was tested 5 times in parallel, and the C2 test results were all positive IgM and positive IgG.