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Title
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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
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Author
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Abstract
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| Background CD4 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. Methods Two 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/mu L thresholds. Results Intra-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/mu L 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/mu L (sensitivity = 87%). All samples could be analyzed as there was no repetitive rejection errors recorded. Conclusions The 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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Language
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English
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Source (journal)
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PLoS ONE
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Publication
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2019
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ISSN
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1932-6203
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DOI
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10.1371/JOURNAL.PONE.0209677
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Volume/pages
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14
:1
(2019)
, 12 p.
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Article Reference
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e0209677
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ISI
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000456442800021
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Pubmed ID
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30673713
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Medium
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E-only publicatie
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Full text (Publisher's DOI)
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Full text (open access)
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