Performance Verification of HIV Test in Blood Station Laboratory / 中国实验血液学杂志

ABSTRACT

OBJECTIVE@#To investigate the methods for verifying and comparing performance of HIV testing methods and procedure analysis in blood station laboratories so as to meet the requirements of ISO15189 accreditation.@*METHODS@#The performance of HIV test was verified by the automatic ELISA analyzer, the intra- and inter-assay precision was analyzed and evaluated by intra- and inter-assay repeat tests, the compliance rate was verified by the test results of the standard serum plate and the external quality assessment from the Ministry of Health in the past 2 years, the limit of detection was verified through continuous dilution of a known amount of reference serum for internal quality control, the status of the instrument was evaluated by testing one HIV-negative specimen, one HIV-negative with other positive markers, one strong HIV-positive specimen and two weak HIV-positive specimens.@*RESULTS@#The intra- and inter-assay precisions were 5.12% and 16.81% respectively, the compliance rate of the serum plate test was 100%, the compliance of the external quality assessment results was 100%, the limits of detection for HIV was 1.42 NCU/ml, and the consistency of the detection systems was 100%.@*CONCLUSION@#The analytical performance of the HIV test methods and procedures accords with the requirements of the reagent instructions, the comparison of the test systems meets the verification requirements.