ArticlePloS one2017
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.
Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 15 citations in OpenAlex.
- Performance of the BD-FACS Presto for CD4 count and hemoglobin measurement in a district hospital and rural laboratory in Ghana.PloS one · 2019Trial
- Performance comparison of CD4 T-cell count instruments based on data from the national proficiency testing program in China, 2016-2023.BMC infectious diseases · 2026Article
- A Prospective Evaluation of the Diagnostic Accuracy of the Point-of-Care VISITECT CD4 Advanced Disease Test in 7 Countries.The Journal of infectious diseases · 2025Article
- Performance Evaluation of BD FACSPrestoDiagnostics (Basel, Switzerland) · 2022Article
- Performance of the BD FACSPresto near to patient analyzer in comparison with representative conventional CD4 instruments in Cameroon.AIDS research and therapy · 2020Article
- Improved Enumeration of Weakly Fluorescent CD4+ T-lymphocytes by Confining Cells in a Spinning Sample Cartridge with a Helical Minichannel.Micromachines · 2020Article
- Assessment of two POC technologies for CD4 count in Morocco.AIDS research and therapy · 2020Article
- Qualitative assessment of South African healthcare worker perspectives on an instrument-free rapid CD4 test.BMC health services research · 2019Article
- Article
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
Abstract
backgroundCD4 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.
methodsPatients 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/μL thresholds.
resultsIntra-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/μL for absolute CD4 counts on capillary blood in Antwerp and Dar es Salaam respectively, vs 12 and 41 cells/μL on venous blood. Bias on CD4% was < 1% on both venous and capillary blood, and was proportionally better than for absolute CD4 counts. Clinical misclassification was in line with the average overestimation, showing a very good specificity, but sensitivity around 70-90%. The rejection rate was 11% on first reading, leading to 6% of all samples without final result after a second reading.
conclusionsThe FACSPresto performed very well on venous blood samples, and well on capillary blood samples.
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