Performance of a parallel diagnostic algorithm for HIV diagnosis in low risk pediatric and obstetric patient populations

J Clin Virol. 2014 Nov;61(3):418-22. doi: 10.1016/j.jcv.2014.08.007. Epub 2014 Aug 17.


Background: Little is known about the clinical performance of the 2010 APHL/CDC Western-blot independent HIV testing algorithm in low risk pediatric and obstetric patients.

Objective: To evaluate the performance of an alternate Western-blot independent algorithm and the individual algorithm components in diagnosing HIV infections in low risk pediatric and obstetric patients.

Study design: 6242 specimens from pediatric and obstetric patients were tested by the Bio-Rad Multispot HIV-1/HIV-2 (MS) and VITROS Anti HIV 1+2 (VITROS) assays. 913 specimens were also tested by the ARCHITECT HIV Ag/Ab Combo assay (ARCHITECT). Discordant specimens were tested by the APTIMA HIV-1 RNA qualitative assay (RNA Qual).

Results: Twenty-eight specimens tested positive for HIV-1 by both MS and VITROS, 4 of these 28 specimens were also tested by and positive by ARCHITECT; all 28 positives identified by the algorithm were positive by viral load analysis. MS identified 164 preliminary positives, which were not confirmed as true positives, representing a specificity of 97.4%. This specificity varied between patient populations (96.1% in the pediatric population and 99.1% in the obstetric population). The specificities of VITROS and ARCHITECT were 99.2% and 99.4% for pediatric patients; 99.7% and 99.8% for obstetric patients, respectively.

Conclusion: Our results highlight suboptimal specificity of MS in pediatric patients, and a lower specificity in both pediatric and obstetric patients relative to either VITROS or ARCHITECT. Additionally, parallel testing with both a third and fourth generation EIA in a low risk patient population provides a potential alternative to Western-blot dependent algorithms for confirmation.

Keywords: HIV diagnosis; Low risk; Obstetric; Pediatric.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adolescent
  • Algorithms*
  • Child
  • Child, Preschool
  • Diagnostic Tests, Routine / methods*
  • Female
  • HIV Infections / diagnosis*
  • Humans
  • Infant
  • Male
  • Obstetrics / methods
  • Pediatrics / methods
  • Sensitivity and Specificity