Near patient CD4 count in a hospitalized HIV patient population

Cytometry B Clin Cytom. 2017 Nov;92(6):451-455. doi: 10.1002/cyto.b.21248. Epub 2015 May 27.


Background: Point-of-care (POC) CD4 T-cell counting is increasingly recognized as providing improved linkage-to-care during management of HIV infection, particularly in resource-limited settings where disease burden is highest. This study evaluated prototype POC CD4 T-cell counters from MBio Diagnostics in the context of low CD4 count, hospitalized patients in Mozambique. This study measured system performance when presented with challenging, low count samples from HIV/AIDS patients with acute illnesses resulting in hospitalization.

Methods: Forty whole blood samples were collected from donors on the medical service at Maputo Central Hospital and absolute CD4 counts were generated on the MBio CD4 system and a reference laboratory using flow cytometry.

Results: The mean and median CD4 counts by the flow cytometry reference were 173 and 80 cells/µL, respectively. Correlation between the MBio CD4 System and the reference was good. Bland-Altman analysis showed a mean bias of +15 cells/µL (+9 to +21 cells/µL, 95% CI), and limits of agreement of -47 to 77 cells/µL. For samples with counts >100 cells/µL (N = 14), the mean coefficient of variation was 7.3%. For samples with counts <50 cells/µL, mean absolute bias of replicate samples was 4.8 cells/µL. When two MBio readers were compared, Bland-Altman bias was -4 cells/µL (-13 to +6 cells/µL, 95% CI), and limits of agreement of -63 and +55 cells/µL.

Conclusions: The MBio System holds promise as a POC system for quantitation of CD4 T cells in resource-limited settings given system throughput (80-100 cartridges/day), design simplicity, and ease-of-use. © 2015 International Clinical Cytometry Society.

Keywords: CD4; HIV; T-cell; diagnostic; point-of-care.

Publication types

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

MeSH terms

  • CD3 Complex / immunology
  • CD4 Lymphocyte Count / instrumentation*
  • CD4-Positive T-Lymphocytes / immunology*
  • CD4-Positive T-Lymphocytes / virology
  • Case-Control Studies
  • Computers, Handheld / economics
  • Computers, Handheld / supply & distribution
  • Developing Countries
  • Flow Cytometry / economics
  • Flow Cytometry / instrumentation*
  • HIV Infections / diagnosis*
  • HIV Infections / immunology
  • HIV Infections / virology
  • Humans
  • Immunophenotyping / instrumentation
  • Immunophenotyping / methods*
  • Lymphocyte Subsets / immunology
  • Lymphocyte Subsets / virology
  • Mobile Applications / economics
  • Mobile Applications / supply & distribution
  • Mozambique
  • Point-of-Care Systems*
  • Reference Standards
  • Reproducibility of Results


  • CD3 Complex