Task-shifting of CD4 T cell count monitoring by the touchscreen-based Muse™ Auto CD4/CD4% single-platform system for CD4 T cell numeration: Implication for decentralization in resource-constrained settings

Kouabosso, André; Mossoro-Kpinde, Christian Diamant; Bouassa, Ralph-Sydney Mboumba; Longo, Jean De Dieu; Simaléko, Marcel Mbeko; Grésenguet, Gérard; Bélec, Laurent

doi:10.1016/j.jim.2018.01.008

Cited by 1 publication

(3 citation statements)

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“…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.…”

Section: Discussionmentioning

confidence: 99%

“…The second study assessed whether the Muse could be used by trained lay providers. Results were found to be less precise and accurate, but the study demonstrated that the instrument can be used to decentralize CD4 counting to health community centers [19].…”

Section: Discussionmentioning

confidence: 99%

“…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].…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2019

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BackgroundCD4 T-cell counts are still widely used to assess treatment eligibility and follow-up of HIV-infected patients. The World Health Organization (WHO) prequalification of in vitro diagnostics requested a manufacturer independent laboratory evaluation of the analytical performance at the Institute of Tropical Medicine (ITM) Antwerp, Belgium, of the Muse Auto CD4/CD4% system (Millipore), a new small capillary-flow cytometer dedicated to count absolute CD4-T cells and percentages in venous blood samples from HIV-infected patients.MethodsTwo hundred and fifty (250) patients were recruited from the HIV outpatient clinic at ITM. Accuracy and precision of CD4 T cell counting on fresh EDTA anticoagulated venous blood samples were assessed in the laboratory on a Muse Auto CD4/CD4% system. Extensive precision analyses were performed both on fresh blood and on normal and low stabilized whole blood controls. Accuracy ((bias) was assessed by comparing results from Muse CD4/CD4% to the reference (single-platform FACSCalibur). Clinical misclassification was measured at 500, 350, 200 and 100 cells/μL thresholds.ResultsIntra-assay precision was < 5%, and inter-assay was < 9%. CD4 T cell counts measured on Muse Auto CD4/CD4% System and on the reference instrument resulted in regression slopes of 0.97 for absolute counts and 1.03 for CD4 T cell percentages and a correlation coefficient of 0.99 for both. The average absolute bias as compared to the reference was negligible (4 cells/μL or 0.5%). The absolute average bias on CD4 T cell percentages was < 1%. Clinical misclassification at different CD4 T cell thresholds was small resulting in sensitivities and specificities equal or >90% at all thresholds except at 100 cells/μL (sensitivity = 87%). All samples could be analyzed as there was no repetitive rejection errors recorded.ConclusionsThe Muse Auto CD4/CD4% System performed very well on fresh venous blood samples and met all WHO acceptance criteria for analytical performance of CD4 technologies.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%