Trial reportPloS one2016
Clinical Evaluation of the BD FACSPresto™ Near-Patient CD4 Counter in Kenya.
Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02396355 (Accuracy Evaluation of the BD FACS Presto System), which is not on this map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Accuracy Evaluation of the BD FACS Presto System: Instrument, Software and BD CD4/%CD4/Hb Cartridge Assay
Who cites it
12 citing papers in PubMed.
- Performance of the BD-FACS Presto for CD4 count and hemoglobin measurement in a district hospital and rural laboratory in Ghana.PloS one · 2019Trial
- Investigating the relationship between the IL-17 rs2275913, IL-17 rs763780, and the IL-6 rs1800795 genotypes in HIV-positive patients with COVID-19.Molecular biology reports · 2025Article
- Comparison of Standard and Point-of-Care CD4+ T Lymphocyte Measurement Methods in HIV-1 Infected Turkish Patients.Medicina (Kaunas, Lithuania) · 2024Article
- Performance Evaluation of BD FACSPrestoDiagnostics (Basel, Switzerland) · 2022Article
- Point-of-care microvolume cytometer measures platelet counts with high accuracy from capillary blood.PloS one · 2021Article
- Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects.Scientific reports · 2020Article
- Performance of the BD FACSPresto near to patient analyzer in comparison with representative conventional CD4 instruments in Cameroon.AIDS research and therapy · 2020Article
- The HIV care continuum and HIV-1 drug resistance among female sex workers: a key population in Guinea-Bissau.AIDS research and therapy · 2020Article
- Point-of-care diagnostics: extending the laboratory network to reach the last mile.Current opinion in HIV and AIDS · 2017Review
- Article
- CD4 Lymphocyte Enumeration and Hemoglobin Assessment Aid for Priority Decisions: A Multisite Evaluation of the BD FACSPrestoThe open AIDS journal · 2017Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe BD FACSPresto™ Near-Patient CD4 Counter was developed to expand HIV/AIDS management in resource-limited settings. It measures absolute CD4 counts (AbsCD4), percent CD4 (%CD4), and hemoglobin (Hb) from a single drop of capillary or venous blood in approximately 23 minutes, with throughput of 10 samples per hour. We assessed the performance of the BD FACSPresto system, evaluating accuracy, stability, linearity, precision, and reference intervals using capillary and venous blood at KEMRI/CDC HIV-research laboratory, Kisumu, Kenya, and precision and linearity at BD Biosciences, California, USA.
methodsFor accuracy, venous samples were tested using the BD FACSCalibur™ instrument with BD Tritest™ CD3/CD4/CD45 reagent, BD Trucount™ tubes, and BD Multiset™ software for AbsCD4 and %CD4, and the Sysmex™ KX-21N for Hb. Stability studies evaluated duration of staining (18-120-minute incubation), and effects of venous blood storage <6-24 hours post-draw. A normal cohort was tested for reference intervals. Precision covered multiple days, operators, and instruments. Linearity required mixing two pools of samples, to obtain evenly spaced concentrations for AbsCD4, total lymphocytes, and Hb.
resultsAbsCD4 and %CD4 venous/capillary (N = 189/ N = 162) accuracy results gave Deming regression slopes within 0.97-1.03 and R2 ≥0.96. For Hb, Deming regression results were R2 ≥0.94 and slope ≥0.94 for both venous and capillary samples. Stability varied within 10% 2 hours after staining and for venous blood stored less than 24 hours. Reference intervals results showed that gender-but not age-differences were statistically significant (p<0.05). Precision results had <3.5% coefficient of variation for AbsCD4, %CD4, and Hb, except for low AbsCD4 samples (<6.8%). Linearity was 42-4,897 cells/μL for AbsCD4, 182-11,704 cells/μL for total lymphocytes, and 2-24 g/dL for Hb.
conclusionsThe BD FACSPresto system provides accurate, precise clinical results for capillary or venous blood samples and is suitable for near-patient CD4 testing.
trial registrationClinicalTrials.gov NCT02396355.
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