Development of External Quality Controls for Human Immunodeficiency Virus Antigen/Antibody Tests in Korea

ABSTRACT

BACKGROUND: Quality control is important for accurate diagnosis of human immunodeficiency virus (HIV) infection, and proficiency testing with external quality controls is an important part of quality control. This study intended to develop and supply customized external quality controls for HIV antigen/antibody testing fitted with currently used reagents for standardization of HIV infection diagnosis and evaluation of HIV testing competency of laboratories in Korea. METHODS: Serological tests and inactivation were performed on the obtained HIV antibody positive plasma. To manufacture quality controls having the required antibody titers, dilution ratio was searched using VIDAS (bioMérieux, France), Architect (Abbott Laboratories, USA), and Cobas 8000 (Roche Diagnostics, Germany) analyzers. Diluted source plasma was divided into aliquots after filtering. Homogeneity and stability of the produced external quality controls were evaluated. RESULTS: The collected HIV antibody positive plasma was confirmed by Western blot. Dilution ratios for source plasma were produced for each analyzer showing signal-to-cut-off 2–3, 5–7, and 15–16 reactivity. Diluted plasma was made to 1 mL aliquots and total set of 1,500 external quality controls for HIV antigen/antibody were manufactured. Produced controls satisfied the required criteria of homogeneity and showed less than 10% coefficient of variation for stability except negative controls. CONCLUSIONS: Customized external quality controls were developed and qualified for HIV testing reagents used in Korea. Continuous external quality control assessment for HIV tests with controls would be required.