close Icon

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

Balakrishnan P, Solomon S, Mohanakrishnan J, Cecelia AJ, Kumarasamy N, Murugavel KG, Venkatakrishnan B, Solomon SS, Crowe SM, Ganesh AK, Thyagarajan SP, Flanigan T, Mayer KH

  • Journal Journal of acquired immune deficiency syndromes (1999)

  • Published 25 Oct 2006

  • Volume 43

  • ISSUE 1

  • Pagination 23-6

  • DOI 10.1097/01.qai.0000227791.92203.d5


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.