Near patient CD4 count in a hospitalized HIV patient population.
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.



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.



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.



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.
MBio Diagnostics Inc., 5603 Arapahoe Ave, Suite 1, Boulder, Colorado, 80303.
Monique
M
Givens
MBio Diagnostics Inc., 5603 Arapahoe Ave, Suite 1, Boulder, Colorado, 80303.
Amanda
A
Weaver
MBio Diagnostics Inc., 5603 Arapahoe Ave, Suite 1, Boulder, Colorado, 80303.
Sarah
S
Bickman
Department of Microbiology, Universidade Eduardo Mondlane, Maputo, Mozambique, Africa.
Cathy
C
Logan
Department of Microbiology, Universidade Eduardo Mondlane, Maputo, Mozambique, Africa.|Division of Infectious Diseases, University of California, San Diego, 9500 Gilman Drive, MC 0711, San Diego, California, 92093.
Emilia V
EV
Noormahomed
Division of Infectious Diseases, University of California, San Diego, 9500 Gilman Drive, MC 0711, San Diego, California, 92093.|Department of Medicine, Universidade Eduardo Mondlane, Maputo, Mozambique, Africa.
Sam
S
Patel
Division of Infectious Diseases, University of California, San Diego, 9500 Gilman Drive, MC 0711, San Diego, California, 92093.
Robert T
RT
Schooley
Division of Infectious Diseases, University of California, San Diego, 9500 Gilman Drive, MC 0711, San Diego, California, 92093.
Constance A
CA
Benson
MBio Diagnostics Inc., 5603 Arapahoe Ave, Suite 1, Boulder, Colorado, 80303.
Michael J
MJ
Lochhead
D017252:CD3 Complex / Q000276:immunology; D018791:CD4 Lymphocyte Count / Q000295:instrumentation*; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology* / Q000821:virology; D016022:Case-Control Studies; D034201:Computers, Handheld / Q000191:economics / Q000600:supply & distribution; D003906:Developing Countries; D005434:Flow Cytometry / Q000191:economics / Q000295:instrumentation*; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D006801:Humans; D016130:Immunophenotyping / Q000295:instrumentation / Q000379:methods*; D016131:Lymphocyte Subsets / Q000276:immunology / Q000821:virology; D063731:Mobile Applications / Q000191:economics / Q000600:supply & distribution; D009073:Mozambique; D019095:Point-of-Care Systems; D012015:Reference Standards; D015203:Reproducibility of Results
D017252:CD3 Complex
CD4; HIV; T-cell; diagnostic; point-of-care