Dataset Information

Clinical Evaluation of the BD FACSPresto™ Near-Patient CD4 Counter in Kenya.

ABSTRACT: The 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.For 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.AbsCD4 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/?L for AbsCD4, 182-11,704 cells/?L for total lymphocytes, and 2-24 g/dL for Hb.The BD FACSPresto system provides accurate, precise clinical results for capillary or venous blood samples and is suitable for near-patient CD4 testing.ClinicalTrials.gov NCT02396355.

SUBMITTER: Angira F

PROVIDER: S-EPMC4970792 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Clinical Evaluation of the BD FACSPresto™ Near-Patient CD4 Counter in Kenya.

Angira Francis F Akoth Benta B Omolo Paul P Opollo Valarie V Bornheimer Scott S Judge Kevin K Tilahun Henok H Lu Beverly B Omana-Zapata Imelda I Zeh Clement C

PloS one 20160802 8

<h4>Background</h4>The 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 bl ...[more]

PMID: 27483008

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Project description:BackgroundDespite the upsurge in support and intervention of donor agencies in HIV care and treatment programing in Sub-Sahara African, antiretroviral (ART) programs are still confronted with access and coverage challenges which influence enrolment of new patients. This study investigated the validity of point of care BD FACSPresto™ CD4 analyzer for CD4+ cell count, overall agreement, correlation, sensitivity, and specificity in comparison to a reference standard flow cytometry method. We also assessed the feasibility of use among non-laboratorians.MethodsBlood samples from 300 HIV infected individuals were analyzed for CD4+ T cell and CD4%, using finger prick capillary sample from 150 PMTCT clients and 150 ART clients at Murtala Mohammed Specialist Hospital, Kano, Nigeria. Their venous samples were compared on a flow cytometry reference method using BD FACSCount CD4+ count system. The accuracy of the BD FACSPresto machine in comparison to BD FACSCount was evaluated. Statistical analysis was carried out using STATA (version 12). Bland-Altman method and correlation analysis were used to analyze agreement between both measurements. In addition, sensitivity and specificity of both measurements were determined. Statistical significance was set at p-value <0.05.ResultsThe mean bias and limit of agreement for CD4+ count between BD FACSPresto and BD FACS count machine were 7.49 (95% CI: 2.44 to 12.54) and -8.14 to 96.39 respectively. Further analysis revealed close agreement between BD FACSPresto and BD FACSCount with no significant difference between the two methods (p = .0.95). Using a threshold of 500 cells/μL, sensitivity and specificity of BD FACSPresto were 95.1% and 97.1% respectively, compared to BD FACSCount. There was no statistically significant difference in the misclassification between BD FACSPresto and BD FACSCount results (p = 0.23). Furthermore, sensitivity and specificity were similar when BD FACSPresto machine was operated by a nurse or laboratory scientist, there was no substantial difference in testing variability observed between laboratory and non-laboratory operators using the BD FACSPresto analyzer.ConclusionsOverall, BD FACSPresto Point of Care CD4+ count finger stick capillary blood results is a reliable method in comparison to venous sample cytometry method and no significant difference variability observed between laboratory personnel and non-laboratory operators. The BD FACSPresto is simple, more robust and easy to use equipment without significant variability in reliability by non-laboratory health care workers hence will be a valuable instrument in increasing access and coverage of CD4 estimations in developing countries. The introduction of the BD FACSPresto POC analyzer has a high potential in reducing patients waiting time and improving the overall quality of ART service and clients' satisfaction especially in rural settings.

Project description:BackgroundIn the context of scaling the viral load in resource limited settings, following HIV infected patient's adults and children with CD4+ T-lymphocyte count still very important in settings where the decentralization of treatment still has some challenges. Effective HIV monitoring in these resource-constrained settings needs affordable and reliable CD4+ T lymphocytes enumeration methods. We investigated the validity of a BD FACSPresto POC which is a dedicated system for enumeration that uses immunofluorescent technologies. In this study, we have assessed the sensitivity, specificity and correlation between most representative flow cytometry instruments present in Cameroon with more than 5000 CD4 T cells tests per year including FACSCalibur, FACSCount, and PIMA POC from Becton-Dickinson and ALERE respectively.Methods268 patients aged from 1 to 72 years old were enrolled and included in the study after inform consent. The BD FACSPresto POC CD4+ T cell technology was placed at CIRCB and operated by technician staff. HIV infected patients were from Chantal BIYA international reference Center (CIRCB), Centre de Sante Catholique de NKOLODOM, Centre de Sante Catholique de BIKOP and CASS de Nkolndongo-Yaounde We compared the accuracy of the BD FACSPresto and three existing reference technologies with more than 5000 tests per year like FACSCalibur, FACSCount and PIMA according to the number of CD4 test done per year and their repartition in the country. Bland-Altman method and correlation analysis were used to estimate mean bias and 95% limits of agreement and to compare the methods, including analysis by subgroup of participant gestational age. In addition sensitivity and specificity were determined. Statistical significance was set at P-value < 0.05.ResultsThe BD FACSPresto POC system has excellent precision, accuracy and linearity for CD4+ T lymphocytes enumeration. Good correlations were obtained between the BD FACSPresto poc system and other single platform methods. Bland-Altman plots showed interchangeability between two machines mean bias BD-FACSPresto vs PIMA = - 126,522(- 161,221 to - 91,822) BD-FACSPresto vs FACSCount = - 38,708 (- 58,935 to - 18,482) and FACSPresto vs FACSCALIBUR = 0.791(- 11,908 to 13,491). Mean difference with Absolute CD4+ T-lymphocyte values obtained from the BD FACSPresto system correlated well with PIMA, FACSCount, and FACSCalibur method with R2 equal to 0.88, 0.92 and 0.968 respectively with P < 0.001 for all. The mean comparison between values obtained from BD FACSPresto with PIMA, FACSCount, and FACSCalibur using paired T test give P = 0.17, P = 0.5 and P = 0.6 respectively meaning that there is no significant differences between values obtained with BD FACSPresto and PIMA, FACSCount or FACSCalibur CD4 enumeration machines. Further analysis revealed close agreement between all the three instruments with no significant difference between the forth methods (P = 0.91).ConclusionThis BD-FACSPresto POC system is a simple, robust and reliable system for enumeration of absolute and percentage of CD4+ T-lymphocytes especially suitable for remote areas with limited resources. Having one BD-FACSPresto POC system easy to use, should reduce the cost and thus increase and improved access to CD4 testing for HIV infected patients in resource-constrained countries. BD-FACSPresto POC CD4 will enable reduction in patient time and improve the overall quality of ART service count and may improve test access in remote areas. This technology can allow for greater decentralization and wider access to CD4 testing and ART.

Dataset Information

Clinical Evaluation of the BD FACSPresto™ Near-Patient CD4 Counter in Kenya.

Publications

Clinical Evaluation of the BD FACSPresto™ Near-Patient CD4 Counter in Kenya.

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