title: Performance evaluation of the touchscreen-based Muse™ Auto CD4/CD4% single-platform system for CD4 T cell numeration in absolute number and in percentage using blood samples from children and adult patients living in the Central African Republic.
abstract: The new microcapillary and fluorescence-based EC IVD-qualified Muse™ Auto CD4/CD4% single-platform assay (EMD Millipore Corporation, Merck Life Sciences, KGaA, Darmstadt, Germany) for CD4 T cell numeration in absolute number and in percentage was evaluated using Central African patients' samples compared against the reference EC IVD-qualified BD FACSCount (Becton-Dickinson, USA) flow cytometer.
  
  
  
  EDTA-blood samples from 124 adults, 10 adolescents, 13 children and 3 infants were tested in parallel at 2 reference laboratories in Bangui.
  
  
  
  The Muse™ technique was highly reproducible, with low intra- and inter-run variabilities less than 15%. CD4 T cell counts of Muse™ and BD FACSCount in absolute number and percentage were highly correlated (r2= 0.99 and 0.98, respectively). The mean absolute bias between Muse™ and BD FACSCount cells in absolute number and percentage were -5.91 cells/µl (95% CI -20.90 to 9.08) with limits of agreement from -77.50 to 202.40 cells/µl, and +1.69 %CD4 (95% CI ±1.29 to +2.09), respectively. The percentages of outliers outside the limits of agreement were nearly similar in absolute number (8%) and percentage (10%). CD4 T cell counting by Muse™ allowed identifying the majority of individuals with CD4 T cell <200, <350 or <750 cells/µl corresponding to the relevant thresholds of therapeutic care, with sensitivities of 95.5-100% and specificities of 83.9-100%.
  
  
  
  The Muse™ Auto CD4/CD4% Assay analyzer is a reliable alternative flow cytometer for CD4 T lymphocyte enumeration to be used in routine immunological monitoring according to World Health Organization recommendations in HIV-infected adults as well as children living in resource-constrained settings.
authors.affiliation: Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, Central African Republic. mossoro_kpinde@yahoo.fr.|Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic. mossoro_kpinde@yahoo.fr.
authors.forename: Christian Diamant
authors.initials: CD
authors.lastname: Mossoro-Kpinde
authors.affiliation: Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic.|Centre National de Référence des Infection Sexuellement Transmissibles et de la Thérapie Antirétrovirale, Bangui, Central African Republic.
authors.forename: André
authors.initials: A
authors.lastname: Kouabosso
authors.affiliation: Laboratoire de virologie, Hôpital Européen Georges Pompidou, Paris, France.|Université Paris Descartes, Paris Sorbonne Cité, Paris, France.
authors.forename: Ralph-Sydney
authors.initials: RS
authors.lastname: Mboumba Bouassa
authors.affiliation: Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic.|Unité de Recherches et d'Intervention sur les Maladies Sexuellement Transmissibles et le SIDA, Département de Santé Publique, Faculté des Sciences de la Santé de Bangui, Bangui, Central African Republic.
authors.forename: Jean De Dieu
authors.initials: JD
authors.lastname: Longo
authors.affiliation: Centre National de Référence des Infection Sexuellement Transmissibles et de la Thérapie Antirétrovirale, Bangui, Central African Republic.
authors.forename: Edouard
authors.initials: E
authors.lastname: Kokanzo
authors.affiliation: Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, Central African Republic.
authors.forename: Rosine
authors.initials: R
authors.lastname: Féissona
authors.affiliation: Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic.|Unité de Recherches et d'Intervention sur les Maladies Sexuellement Transmissibles et le SIDA, Département de Santé Publique, Faculté des Sciences de la Santé de Bangui, Bangui, Central African Republic.
authors.forename: Gérard
authors.initials: G
authors.lastname: Grésenguet
authors.affiliation: Laboratoire de virologie, Hôpital Européen Georges Pompidou, Paris, France.|Université Paris Descartes, Paris Sorbonne Cité, Paris, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Bélec
mesh_terms: D000293:Adolescent; D000328:Adult; D018791:CD4 Lymphocyte Count / Q000295:instrumentation*; D015496:CD4-Positive T-Lymphocytes / Q000166:cytology* / Q000276:immunology*; D002488:Central African Republic; D002648:Child; D015658:HIV Infections / Q000276:immunology; D006801:Humans; D007223:Infant; D016014:Linear Models; D012680:Sensitivity and Specificity
keywords: CD4 T cell count; Central Africa; Flow cytometry; Muse™ cell analyzer; Resource-limited settings; Single-platform