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

• Published in: Journal of translational medicine 2016-11, Vol.14 (1), p.326-326, Article 326
• Main Authors: Mossoro-Kpinde, Christian Diamant, Kouabosso, André, Mboumba Bouassa, Ralph-Sydney, Longo, Jean De Dieu, Kokanzo, Edouard, Féissona, Rosine, Grésenguet, Gérard, Bélec, Laurent
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; CD4 Lymphocyte Count - instrumentation; CD4 T cell count; CD4-Positive T-Lymphocytes - cytology; CD4-Positive T-Lymphocytes - immunology; Central Africa; Central African Republic; Child; Comparative analysis; Flow cytometry; Fluorescence; Health aspects; HIV Infections - immunology; HIV patients; Humans; Infant; Linear Models; Muse™ cell analyzer; Performance evaluation; Resource-limited settings; Sensitivity and Specificity; Single-platform; T cells
• ISSN: 1479-5876; 1479-5876
• DOI: 10.1186/s12967-016-1082-7

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 (r  = 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