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Title: CD4 lymphocyte enumeration and hemoglobin assessment aid for priority decisions: A multisite evaluation of the BD FACSPresto™ system
Authors: Madhuri Thakar
Francis Angira
Kovit Pattanapanyasat
Alan H.B. Wu
Maurice O’Gorman
Hui Zeng
Chenxue Qu
Bharati Mahajan
Kasama Sukapirom
Danying Chen
Yu Hao
Yan Gong
Monika de Arruda Indig
Sharon Graminske
Diana Orta
Nicole d’Empaire
Beverly Lu
Imelda Omana-Zapata
Clement Zeh
National AIDS Research Institute India
Kenya Medical Research Institute
Centers for Disease Control and Prevention
Mahidol University
San Francisco General Hospital and Trauma Center
University of Southern California
Beijing Ditan Hospital
Peking University
BloodCenter of Wisconsin
BioCollections Worldwide Inc.
BD Biosciences
Keywords: Immunology and Microbiology
Issue Date: 1-Oct-2017
Citation: Open AIDS Journal. Vol.11, (2017), 76-90
Abstract: © 2017 Thakar et al. Background: The BD FACSPresto™ system uses capillary and venous blood to measure CD4 absolute counts (CD4), %CD4 in lymphocytes, and hemoglobin (Hb) in approximately 25 minutes. CD4 cell count is used with portable CD4 counters in resource-limited settings to manage HIV/AIDS patients. A method comparison was performed using capillary and venous samples from seven clinical laboratories in five countries. The BD FACSPresto system was assessed for variability between laboratory, instrument/operators, cartridge lots and within-run at four sites. Methods: Samples were collected under approved voluntary consent. EDTA-anticoagulated venous samples were tested for CD4 and %CD4 T cells using the gold-standard BD FACSCalibur™ system, and for Hb, using the Sysmex® KX-21N™ analyzer. Venous and capillary samples were tested on the BD FACSPresto system. Matched data was analyzed for bias (Deming linear regression and Bland- Altman methods), and for concordance around the clinical decision point. The coefficient of variation was estimated per site, instrument/operator, cartridge-lot and between-runs. Results: For method comparison, 93% of the 720 samples were from HIV-positive and 7% from HIV-negative or normal subjects. CD4 and %CD4 T cells venous and capillary results gave slopes within 0.96 1.05 and R2 ≥0.96; Hb slopes were ≥1.00 and R2 ≥0.89. Variability across sites/operators gave %CV <5.8% for CD4 counts, <1.9% for %CD4 and <3.2% for Hb. The total %CV was <7.7% across instrument/cartridge lot. Conclusion: The BD FACSPresto system provides accurate, reliable, precise CD4/%CD4/Hb results compared to gold-standard methods, irrespective of venous or capillary blood sampling. The data showed good agreement between the BD FACSPresto, BD FACSCalibur and Sysmex systems.
ISSN: 18746136
Appears in Collections:Scopus 2016-2017

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