Sinoway Industrial Co., Ltd.  

Product Description [Product Performance]1.Lowest limit of detectionTest with the in-house LOD references. S1 and S2 are positive for IgG antibody, negative for IgM antibody; S3 is negative for IgG/IgM antibodies; S4 and S5 are positive for IgM antibody, negative for IgG antibody; and S6 is negative for IgG/IgM antibodies.2.Negative coincidence rateTest with the in-house negative references, and the results are all negative for IgG/IgM antibodies, with a coincidence rate of 100%.3.Positive coincidence rateTest with the in-house positive references. PC01-PC05 are all positive for IgG/IgM antibodies, with a coincidence of 100%; PC06-PC10 are all negative for IgG antibody, and all positive for IgM antibody, with a coincidence rate of 100%; PC11-PC15 are all negative for IgM antibody, and all positive for IgG antibody, with a coincidence rate of 100%.4.PrecisionIntra-batch difference: Test with the in-house repetitive references. CV1 and CV2 are positive for IgG antibody and negative for IgM antibody; CV3 andCV4 are negative for IgG antibody and positive for IgM antibody, with uniform color development.Inter-batch difference: Test with the in-house repetitive references. The results of the kit of three batch numbers are shown as follows: CV1 and CV2 are positive for IgG antibody and negative for IgM antibody; CV3 and CV4 are negative for IgG antibody and positive for IgM antibody, with uniform color development.