Standardization and monitoring of laboratory performance and quality assurance by use of the less-sensitive HIV incidence assay: seven years of results.

Background: The Performance Evaluation Program for HIV-1 incidence tests provided quality assurance services to laboratories conducting the serological testing algorithm for recent HIV seroconversion by use of a modified less-sensitive version of the Vironostika HIV-1 MicroElisa System assay. We report on the performance of the assay using proficiency testing and quality control materials tested from 2001 to 2008.

Methods: Two sets of 5 blinded serum panels using common calibration and quality control materials were tested. The mean, standard deviation, and coefficient of variation were calculated. Results were analyzed for misclassifications: false recent HIV infection errors (long-term infection classified as HIV infection less than 1 year), false long-term infection errors (HIV infection less than 1 year classified as long-term infection), and differences in standardized optical density means and variances over time.

Results: The false recent error rate was 1.26% (n = 2219). The false long-term error rate was 0.25% (n = 1618). No significant trends were observed for misclassification rates by year, and no significant trend in the standardized optical density over 7 years was observed.

Conclusions: Laboratories using the less-sensitive Vironostika HIV-1 assay produced consistent results by use of a common calibrator and quality control materials.