The verification of the performance of the ELISA kit of HIV antibody

Objective To verify the performance of the ELISA kit of HIV antibody in order to know whether the kit is fit for screening test.Methods The minimum detection limit,the precision includes repeatability and intermediate precision,the negative and positive coincidence rate were determined.The CUTOFF value was also evaluated.Results Through the experimental study,the minimum detection limit of the kit was 0.125 NCU/ml.The CV% of variations of repeatability test of the test samples and normal people samples were 5.6% and 6.4%,respectively.The CV% of variation of intermediate precision test was 10.9% .The negative and positive coincidence rates of the kit were both 100% .In the verifying test of CUTOFF value,the (±3SD) of the OD of the detected results was 0.038,which was less than the CUTOFF value of the kit.Conclusion The ELISA kit is fit for screening test.