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Title
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Performance of FACSPresto point-of-care instrument for CD4-T cell enumeration in Human Immunodeficiency Virus (HIV)-infected patients attending care and treatment clinics in Belgium and Tanzania
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Author
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Abstract
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| Background CD4 T-cell counts are widely used to assess treatment eligibility and to follow-up HIV-infected patients. The World Health Organization prequalification of in vitro diagnostics program conducted a performance evaluation of the FACSPresto (BD Biosciences), a new point-of-care instrument to measure absolute CD4-T cell (CD4) counts and percentages in venous and capillary blood samples from HIV-infected patients. Methods Patients were recruited in Belgium (200 patients) and in Tanzania (247 patients). Venous blood samples were analyzed in two nearby reference laboratories. In addition, nurses/technicians collected a capillary blood sample by finger prick directly into a FACSPresto CD4 cartridge. Assay precision was assessed on fresh blood and on external quality control samples. Trueness (bias) was assessed by comparing results from FACSPresto with the reference (single-platform FACSCalibur). Clinical misclassification was measured at 200, 350 and 500 cells/mu L thresholds. Results Intra-assay precision was < 6%, and inter-assay < 8%. CD4 results from FACSPresto and reference method resulted in regression slopes of 0.99-1.11 using either venous or capillary blood. Correlation was better for venous than for capillary blood (minimum 0.97 vs 0.93 respectively). Capillary blood resulted in a larger bias than venous blood, with 24 and 83 cells/mu L for absolute CD4 counts on capillary blood in Antwerp and Dar es Salaam respectively, vs 12 and 41 cells/mu L on venous blood. Bias on CD4% was < 1% on both venous and capillary blood, and was proportionally better than for absolute CD4 counts. Clinical |
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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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2017
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ISSN
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1932-6203
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DOI
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10.1371/JOURNAL.PONE.0170248
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Volume/pages
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12
:1
(2017)
, 16 p.
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Article Reference
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e0170248
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ISI
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000396211400059
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Pubmed ID
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28129324
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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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