J Clin Pathol Qual Control.  1999 Dec;21(2):355-362.

Report on External Quality Assessment of HIV Antibody Test (1998)

• Lee JS
• Park KY
• Kim SS
• Suh SD
• Park HK
• Hwang YS
• Hwang BK
• Lee YR
• Cho JJ
• Kim HS
• Yong DE
• Kim YN

Abstract

BACKGROUND: High accuracy is required for the diagnosis of HIV infection. To establish national quality assurance program (QAP) in Korea, our laboratory has developed quality assessment (QA) and quality control (QC) program. We here report the result of quality assessment in which 150 laboratories were participated.
METHODS
Two trials of external quality assessment of HIV antibody test were performed in 1998. A total of 12 sera including five undiluted and one diluted HIV-1 antibody positive sera, one HIV-2 antibody positive serum and five HIV negative sera were distributed to the 158 participating laboratories with a questionnaire.
RESULTS
The percentage of reporting the test result was 88.7% for the 1st trial and 57.6% for the 2nd trial. The analytic sensitivity and specificity of EIA HIV-1/2 antibody test for 10 undiluted quality assessment samples were 100% and 99.1%, respectively. Both analytic sensitivity and analytic specificity of PA test were 100%. In case of one diluted serum, the analytic sensitivity of EIA and PA was 98.6% and 100%, respectively.
CONCLUSIONS
Most participant laboratories performed well in testing the HIV samples in our quality assessment. No false negative result were reported in EIA and PA for anti-HIV. However, false positive EIA result were reported infrequently for samples negative for HIV antibody. This accurate and reliable testing will be maintained and improved by the quality assessment and quality control programs.

MeSH Terms

Blotting, Western
Diagnosis
HIV Infections
HIV*
HIV-1
HIV-2
Immunoenzyme Techniques
Korea
Quality Control
Sensitivity and Specificity
Surveys and Questionnaires