title: Standardization and monitoring of laboratory performance and quality assurance by use of the less-sensitive HIV incidence assay: seven years of results.
abstract: 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.
authors.affiliation: Division of Laboratory Sciences, Centers for Disease Control and Prevention, Atlanta, GA, USA. jmei@cdc.gov
authors.forename: Joanne V
authors.initials: JV
authors.lastname: Mei
authors.forename: Meredith
authors.initials: M
authors.lastname: Kennedy
authors.forename: Laurie
authors.initials: L
authors.lastname: Linley
authors.forename: Debra
authors.initials: D
authors.lastname: Hanson
authors.forename: Jarad
authors.initials: J
authors.lastname: Schiffer
authors.forename: Steven
authors.initials: S
authors.lastname: Ethridge
authors.forename: Bernard
authors.initials: B
authors.lastname: Branson
mesh_terms: D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000453:epidemiology*; D006679:HIV Seropositivity / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology / Q000302:isolation & purification; D006801:Humans; D007753:Laboratories / Q000592:standards*; D011237:Predictive Value of Tests; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000592:standards*
chemical_list: D015483:HIV Antibodies