Performance Verification of HIV Test in Blood Station Laboratory.
10.19746/j.cnki.issn.1009-2137.2019.04.048
- Author:
Ya-Jun LIU
1
;
Jun ZHOU
2
Author Information
1. Xianyang Blood Station, Xianyang 712046, Shaanxi Province, China.
2. Xianyang Blood Station, Xianyang 712046, Shaanxi Province, China,E-mail: 124326760@qq.com.
- Publication Type:Journal Article
- MeSH:
Enzyme-Linked Immunosorbent Assay;
HIV;
Mass Screening;
Quality Control;
Serologic Tests
- From:
Journal of Experimental Hematology
2019;27(4):1287-1290
- CountryChina
- Language:Chinese
-
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.
