Post-evaluation of rapid HIV kits in the Korean market by an anti-HIV EQAS panel

Abstract

This study aimed to provide evaluation information about rapid HIV kits by the anti-HIV External Quality Assessment Schemes (EQAS) panel of the Korea National Institute of Health (KNIH) and the rapid HIV test panel of the US Centers for Disease Control and Prevention (CDC). Each KNIH anti-HIV EQAS panel from 2003 to 2005 consisted of four or five samples of plasma obtained from blood donors with a strong positive or negative reaction to HIV. KNIH delivered each panel to public health centers for analysis of the HIV test results, and the reactivity of the five rapid HIV kits currently used in the Korean market were compared with that of a CDC reference. The analytic sensitivity and specificity of the rapid HIV kits for the KNIH anti-HIV EQAS in 2005 were 99.3 and 99.1%, respectively; in 2004, 98.8 and 97.1%; and in 2003, 94.8 and 95.9%. Five HIV kits from the CDC panel consistently showed positive reactivity for strong positive samples in all kits, but some showed erratic reactivity for weakly positive samples. This is the first report on post-evaluation of rapid HIV kits in the Korean market by an anti-HIV EQAS panel. It was found that the quality of performance of the rapid HIV tests had improved each year but should be interpreted with caution for weakly positive samples.