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Published on: October 31, 2010
[Performance Verification of HIV Test in Blood Station Laboratory]
1Xianyang Blood Station, Xianyang 712046, Shaanxi Province, China.
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.
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