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  • 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.
    Author: Mossoro-Kpinde CD, Kouabosso A, Mboumba Bouassa RS, Longo JD, Kokanzo E, Féissona R, Grésenguet G, Bélec L.
    Journal: J Transl Med; 2016 Nov 25; 14(1):326. PubMed ID: 27884153.
    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.
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