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

Journal of Translational Medicine

Edouard Kokanzo¹  André Kouabosso²  Gérard Grésenguet²  Jean De Dieu Longo²  Christian Diamant Mossoro-Kpinde³  Rosine Féissona³  Laurent Bélec⁴  Ralph-Sydney Mboumba Bouassa⁴ 

[1] Centre National de Référence des Infection Sexuellement Transmissibles et de la Thérapie Antirétrovirale;Faculté des Sciences de la Santé, Université de Bangui;Laboratoire National de Biologie Clinique et de Santé Publique;Laboratoire de virologie, Hôpital Européen Georges Pompidou;

关键词: Single-platform;    Flow cytometry;    Muse™ cell analyzer;    CD4 T cell count;    Resource-limited settings;    Central Africa;   

DOI  :  10.1186/s12967-016-1082-7

来源: DOAJ

【 摘 要 】

Abstract Background 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. Methods EDTA-blood samples from 124 adults, 10 adolescents, 13 children and 3 infants were tested in parallel at 2 reference laboratories in Bangui. Results 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%. Conclusions 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.

【 授权许可】

Unknown