CD4 Lymphocyte Enumeration and Hemoglobin Assessment Aid for Priority Decisions: A Multisite Evaluation of the BD FACSPresto™ System
| Autor: | Chenxue Qu, Francis Angira, Hui Zeng, Monika de Arruda Indig, Yu Hao, Maurice R.G. O'Gorman, Bharati Mahajan, Yan Gong, Danying Chen, Beverly Lu, Diana Orta, Clement Zeh, Sharon Graminske, Alan H.B. Wu, Imelda Omana-Zapata, Kasama Sukapirom, Madhuri Thakar, Kovit Pattanapanyasat, Nicole d’Empaire |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Concordance Coefficient of variation HIV-1 diversity Article Capillary 03 medical and health sciences 0302 clinical medicine Virology Linear regression Enumeration Medicine Capillary blood sampling Hemoglobin 030212 general & internal medicine business.industry Recent infections Public Health Environmental and Occupational Health Venous blood Precision Venous 030112 virology CD4 Infectious Diseases HIV/AIDS CD4 Lymphocyte Nuclear medicine business |
| Zdroj: | The Open AIDS Journal |
| ISSN: | 1874-6136 |
| DOI: | 10.2174/1874613601711010076 |
| Popis: | 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 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. |
| Databáze: | OpenAIRE |
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