Background: The new microcapillary and fluorescence-based EC IVD-qualified Museââ??¢ Auto CD4/CD4% singleplatform\nassay (EMD Millipore Corporation, Merck Life Sciences, KGaA, Darmstadt, Germany) for CD4 T cell numeration\nin absolute number and in percentage was evaluated using Central African patientsââ?¬â?¢ samples compared against the\nreference EC IVD-qualified BD FACSCount (Bectonââ?¬â??Dickinson, USA) flow cytometer.\nMethods: EDTA-blood samples from 124 adults, 10 adolescents, 13 children and 3 infants were tested in parallel at 2\nreference laboratories in Bangui.\nResults: The Museââ??¢ technique was highly reproducible, with low intra- and inter-run variabilities less than 15%. CD4\nT cell counts of Museââ??¢ and BD FACSCount in absolute number and percentage were highly correlated (r2 = 0.99 and\n0.98, respectively). The mean absolute bias between Museââ??¢ and BD FACSCount cells in absolute number and percentage\nwere âË?â??5.91 cells/Ã?¼l (95% CI âË?â??20.90 to 9.08) with limits of agreement from âË?â??77.50 to 202.40 cells/Ã?¼l, and +1.69\n
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