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

BackgroundThe 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.MethodsEDTA-blood samples from 124 adults, 10 adolescents, 13 children and 3 infants were tested in parallel at 2 reference laboratories in Bangui.ResultsThe 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%.ConclusionsThe 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.

Integrated data analysis reveals potential drivers and pathways disrupted by DNA methylation in papillary thyroid carcinomas

“…Previously, we pointed out GABRB2 and HMGA2 as potential diagnostic makers in thyroid tumors [26]. HMGA2 interacts with the transcription machinery (acts in the chromatin structure and regulates the transcription) and in the epithelial-mesenchymal transition (by repression of E-cadherin) [47, 50, 51]. Although HMGA2 and GABRB2 were not associated with clinical features or somatic alterations in the large-scale expression analysis, the independent validation demonstrated that GABRB2 hypomethylation and overexpression were significantly altered in BRAF V600E tumors.…”

Diagnosis of Human Immunodeficiency Virus Infection

“…Another POC CD4 technology is the EMD Millipore Muse Auto CD4/CD4% system (367,368). This technology replaces the discontinued Guava Auto CD4%/CD4 system.…”

CD4-T cell enumeration in human immunodeficiency virus (HIV)-infected patients: A laboratory performance evaluation of Muse Auto CD4/CD4% system by World Health Organization prequalification of in vitro diagnostics

“…Until today, two field studies of the Muse Auto CD4/CD4% have been published, both by the same group [18,19]. One study, conducted in the Central African Republic, also looked at analytical performance, and although the number of enrolled patients was smaller than requested by WHO prequalification, and a FACSCount was used as predicate instrument, both precision and bias estimates were within the WHO acceptance criteria.…”

“…The instrument requires a laboratory, stable power supply and skilled laboratory personnel but it uses very small amounts of anticoagulated blood (10μL) and reagents, and produces a result within 30–40 minutes. Preliminary field tests of this small flow cytometer have shown very promising results [18,19]. The present study is the first manufacturer-independent study of the Muse Auto CD4/CD4% System in accordance with the WHO protocol for performance evaluation of CD4 technologies in a reference laboratory [20,21].…”