CD4 Lymphocyte Enumeration and Hemoglobin Assessment Aid for Priority Decisions: A Multisite Evaluation of the BD FACSPresto System



Madhuri Thakar1, Francis Angira2, Kovit Pattanapanyasat4, Alan H.B. Wu5, Maurice O’Gorman6, Hui Zeng7, Chenxue Qu8, Bharati Mahajan1, Kasama Sukapirom4, Danying Chen7, Yu Hao7, Yan Gong8, Monika De Arruda Indig9, Sharon Graminske9, Diana Orta10, Nicole d’Empaire10, Beverly Lu11, Imelda Omana-Zapata11, *, Clement Zeh3
1 National AIDS Research Institute, Pune, India
2 Kenya Medical Research Institute/US CDC Research and Public Health Collaboration, Kisumu, Kenya
3 US Centers for Disease Control and Prevention (CDC-Kenya), Kisumu, Kenya
4 Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
5 San Francisco General Hospital, San Francisco, CA, USA
6 Children’s Hospital Los Angeles, Los Angeles, and The Keck School of Medicine, University of Southern California, CA, USA
7 Beijing Ditan Hospital, Capital Medical University, Beijing, China
8 Peking University First Hospital, Beijing, China
9 BloodCenter of Wisconsin, Milwaukee, Wisconsin, USA
10 BioCollection Worldwide Incorporated, Miami, Florida, USA
11 BD Biosciences, San Jose, California, USA


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© 2017 Thakar et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at the BD Biosciences, San Jose, California, USA, Tel: (1) 408-954-2323, Fax: (1) 408-954-6313; E-mail: imelda.omana-zapata@bd.com


Abstract

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.

Keywords: CD4, HIV/AIDS, Hemoglobin, Venous, Capillary, HIV-1 diversity, Recent infections, Precision.