6 Technical indicators for evaluation method evaluation 6.1.1 Kits are divided into qualitative detection kits and quantitative detection kits. Test reports issued using qualitative test kits only issue negative and positive judgment results and do not report specific test values. Use the test report issued by the quantitative test kit test to report the test value above the quantitative limit. 6.1.2 Qualitative detection kits need to be evaluated for sensitivity, specificity, and false negative rate/false positive rate. Quantitative detection reagents T/CHBAS21-2022 4 kits need to be evaluated for linearity and range, detection limit, quantification limit, accuracy, and precision.
T/CHBAS 21-2022 history
2022T/CHBAS 21-2022 Technical regulations for the production of dafloxacin biological barcode detection kit