Evaluation of PIMA™® point of care technology for CD4 T cell enumeration in Kenya

PLoS One. 2013 Jun 25;8(6):e67612. doi: 10.1371/journal.pone.0067612. Print 2013.

Abstract

CD4+ T cell enumeration is used to determine eligibility for antiretroviral therapy (ART) and to monitor the immune status of HIV-positive patients; however, many patients do not have access to this essential diagnostic test. Introducing point of care (POC) testing may improve access. We have evaluated Alere's PIMA™, one such POC device, against conventional CD4+ testing platforms to determine its performance and validity for use in Kenya. In our hands, Alere PIMA™ had a coefficient of variability of 10.3% and of repeatability of 175.6 cells/µl. It differed from both the BD FACSCalibur™ (r(2) = 0.762, mean bias -64.8 cells/µl), and the BD FACSCount™ (r(2) = 0.874, mean bias 7.8 cells/µl). When compared to the FACSCalibur™ at a cutoff of 350 cells/µl, it had a sensitivity of 89.6% and a specificity of 86.7% in those aged 5 years and over (Kw = 0.7566). With the BD FACSCount™, it had a sensitivity of 79.4% and a specificity of 83.4% in those aged 5 years and over (Kw = 0.7790). The device also differed from PARTEC Cyflow™ (r(2) = 0.781, mean bias -24.2 cells/µl) and GUAVA™ (r(2) = 0.658, mean bias -0.3 cells/µl) platforms, which are used in some facilities in Kenya. We conclude that with refinement, Alere PIMA™ technology has potential benefits for HIV-positive patients. This study highlights the difficulty in selecting the most appropriate reference technology for technical evaluations.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • CD4-Positive T-Lymphocytes / cytology*
  • Cell Count / methods*
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Infant
  • Kenya
  • Linear Models
  • Male
  • Middle Aged
  • Point-of-Care Systems*
  • Young Adult