•Positive reference for QC: use three positive corporate reference materials (P1-P3) for testing, and the result should be positive.
•Negative references for QC: Three types of negative reference materials (N1-N3) have been tested, and the results should be negative.
•Minimum detection limit: three corporate sensitivity reference materials (L 1, L2, L3) are used for testing, and each sample is repeated 3 times. The L1 test results should all be positive, and the L2 and L3 test results should both be negative.
•Repeatability: Tested the repeatability of three reference products. Each test is repeated 10 times and should be positive.
•Sensitivity: 92.11% (35/38, 95% CI, 78.62% - 98.34%)
•Specificity: 100.00% (50/50, 95% CI, 92.89% - 100.00%)