A reliable and inexpensive EasyCD4 assay for monitoring HIV-infected individuals in resource-limited settings

J Acquir Immune Defic Syndr. 2006 Sep;43(1):23-6. doi: 10.1097/01.qai.0000227791.92203.d5.

Abstract

Serial measurements of absolute CD4+ T-lymphocyte counts are required to initiate and gauge response to therapy and monitor disease progression. Hence, there is an urgent need to evaluate the accuracy and validity of low-cost CD4+ T-cell count assays. Tripotassium EDTA blood specimens from HIV-infected individuals were studied using a novel flow cytometric assay (EasyCD4 assay; Guava Technologies, Hayward, CA) in comparison with standard flow cytometry (FACSCount; Becton Dickinson Immunocytometry Systems, San Jose, CA). The sensitivity, specificity value by EasyCD4 assay in enumerating absolute CD4+ T-cell counts of less than 200 cells/microL were 95% and 100%, respectively. Bland-Altman analysis showed close agreement, with the EasyCD4 assay yielding CD4+ T-cell counts a mean difference of -26 cells/microL (95% confidence interval, -96 to 44 cells/microL) higher than by flow cytometry. Our data suggest that EasyCD4 assay could be a useful alternative assay to conventional flow cytometry, may be appropriate for use in resource-limited settings.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • CD4 Lymphocyte Count / economics
  • CD4 Lymphocyte Count / methods*
  • Child
  • Costs and Cost Analysis
  • Flow Cytometry / methods
  • HIV Infections / diagnosis
  • HIV Infections / immunology*
  • Humans
  • India
  • Middle Aged
  • Monitoring, Immunologic
  • Reproducibility of Results
  • Resource Allocation