Dataset Information

The performance of BD FACSPresto™ for CD4 T-cell count, CD4% and hemoglobin concentration test in Ethiopia.

ABSTRACT:

Introduction

In Ethiopia, CD4+ T-cell counting is still required for all patients at baseline before antiretroviral therapy (ART) and to determine eligibility and follow-up of opportunistic infection prophylaxis. However, access to CD4+ T cell count in rural health facilities remains a major challenge in Ethiopia like other resource-limited settings.

Methodology

Both capillary and venous blood was drawn from each of 325 study participant recruited in Addis Ababa and surroundings. The CD4+ T-cell count, CD4%, and hemoglobin (Hgb) were tested at one of the four study health facilities using capillary blood and BD FACSPresto™ device. These tests were also done at the national HIV reference laboratory, using venous blood with BD FACSCalibur™, Sysmex XT-1800i™, and BD FACSPresto™.

Results

BD FACSPresto™ had an absolute mean bias of -13.3 cells/ul (-2.99%) and 28.3 cells/?l (6.4%) using venous and capillary blood, respectively, compared with BD FACSCalibur™. The absolute CD4 assay on the BD FACSPresto™ had a regression coefficient (R2) of 0.87 and 0.92 using capillary blood and venous blood samples, respectively, compared with BD FACSCalibur™. The percentage similarity of the BD FACSPresto™ using capillary and venous blood was 105.2% and 99.3%, respectively. The sensitivity of the FACSPresto™ using threshold of 500 cells/?l for ART eligibility using capillary and venous blood was 87.9 and 94.3%, while the specificity was 91.4 and 83.8%, respectively. Furthermore, the BD FACSPresto™ had an absolute mean bias of -0.2 dl/?l (0.0%) (95% LOA: -1.7, 1.3) and -0.59 dl/?l (0.1%) (95% LOA: -1.49, 0.31) for Hgb using capillary and venous blood compared with the Sysmex XT-1800i™, respectively.

Conclusion

Our results showed acceptable agreement between the BD FACSPresto™ and BD FACSCalibur™ for CD4+ T-cell counting and CD4%; and between the BD FACSPresto™ and Sysmex XT-1800i™for measuring Hgb concentration.

SUBMITTER: Gebremicael G

PROVIDER: S-EPMC5407647 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

The performance of BD FACSPresto™ for CD4 T-cell count, CD4% and hemoglobin concentration test in Ethiopia.

Gebremicael Gebremedhin G Belay Yohanes Y Girma Fitsum F Abreha Yemane Y Gebreegziabxier Atsbeha A Tesfaye Simret S Messele Zelalem Z Assefa Yibeltal Y Bellete Bahrie B Kassa Desta D Vojnov Lara L

PloS one 20170427 4

<h4>Introduction</h4>In Ethiopia, CD4+ T-cell counting is still required for all patients at baseline before antiretroviral therapy (ART) and to determine eligibility and follow-up of opportunistic infection prophylaxis. However, access to CD4+ T cell count in rural health facilities remains a major challenge in Ethiopia like other resource-limited settings.<h4>Methodology</h4>Both capillary and venous blood was drawn from each of 325 study participant recruited in Addis Ababa and surroundings. ...[more]

PMID: 28448581

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Project description: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.

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:IntroductionIn Ghana, initiation of Antiretroviral Therapy (ART) is recommended for all patients with an HIV diagnosis, regardless of CD4+ T-cell count. However, measurement of CD4 count remains an important metric for identifying patients with advanced HIV disease, and assessing a person's overall immune status, which informs the decision to offer opportunistic infection screening and prophylaxis. Access to CD4+ T cell count in rural health facilities remains a major challenge in Ghana and other resource-limited settings. This study aimed to validate the accuracy of the BD FACSPresto near-patient device for measurement of CD4 count and hemoglobin concentration against the FACSCount (CD4) and Sysmex (hemoglobin) diagnostic machines when operated in both a district hospital and rural laboratory, serving a network of health posts in Ashanti Region, Ghana.MethodologyIn the first phase of the study, patients were recruited from a district hospital, and both venous and capillary blood samples were tested using the FACSCount and Sysmex as reference tests and compared to results of the FACSPresto performed in the clinic laboratory at the district hospital. In the second phase, patients were recruited from both the hospital and from rural health clinics, and samples were tested using the FACSPresto at a rural laboratory. Sensitivity and specificity among samples categorized into different clinically relevant CD4 count ranges were calculated, along with correlation between the Presto and the reference measurements, and mean and relative bias with limits of agreement.ResultsThe FACSPresto was successfully operated in both clinical settings. A total of 59 samples in the first phase and 48 samples in the second phase were included. Positive bias was observed when comparing CD4 count measured by BD FACSPresto to FACSCount in the district hospital (bias = 44, LOA -72,160) and in the rural laboratory setting (bias = 74, LOA -96, 244). In addition, capillary blood samples were shown to give higher measures when compared to venous blood samples from the same participant. All results were statistically significant (p<0.05) apart from hemoglobin measurement in venous blood in the rural laboratory. Correlation coefficients were high for CD4 count measures and lower for hemoglobin measures.ConclusionOverall, the Presto gave higher estimates of CD4 count compared to FACSCount, and hemoglobin measurements were higher than from Sysmex. Samples of capillary blood in turn gave higher results for both measurements compared to venous blood, consistent with previous analyses. These findings should be considered when selecting CD4 count machines for use at the point of care, especially in remote areas where capillary blood sampling may be preferable, but are likely balanced by device's ease of use, portability, and ability to expand access to services. These results are some of the first to demonstrate the accuracy of the FACSPresto in West Africa and show that this device can be successfully operated in a very rural lab setting and may therefore assist to provide CD4 count and hemoglobin concentration measurement to populations in need.

Project description:BackgroundEven though there are advancements in HIV/AIDS prevention and treatment approach, HIV continues to be a global challenge. Pediatrics HIV is one of the challenges in the reduction of child mortality particularly in less developed countries like Ethiopia. Therefore, this study aims to estimate the pooled proportion of child mortality and the effect of hemoglobin level and CD4 cell count among children on antiretroviral therapy in Ethiopia.MethodAll published were articles searched using PubMed, EMBASE, Google Scholar, and Web of Science database. Besides, Ethiopian institutional research repositories and reference lists of included studies were used. We limited the searching to studies conducted in Ethiopia and written in the English language. Studies that were done in a cohort, cross-sectional, and case-control study design were considered for the review. The weighted inverse variance random effects model was applied, and the overall variations between studies were checked by using heterogeneity test Higgins's (I 2). Subgroup analysis by region and year of publication was conducted. All of the included articles were assessed using the Joanna Briggs Institute (JBI) quality appraisal criteria. In addition, publication bias was also checked with Egger's regression test and the funnel plot. Based on the results, trim and fill analysis was performed to manage the publication bias.ResultA total of 16 studies with 7047 participants were included in this systematic review and meta-analysis. The overall pooled proportion of mortality among children on antiretroviral therapy (ART) was found to be 11.78% (95% CI 9.34, 14.23). In subgroup analysis, the highest child mortality was observed in the Amhara region 16.76 % (95% CI 9.63, 23.90) and the lowest is in the Tigray region 4.81% (95% CI 2.75, 6.87). Besides, the proportion of mortality among children with low CD4 count and hemoglobin level was 2.42 (AOR = 2.42, 95% CI 1.65, 3.56) and 3.24 (AOR = 3.24, 95% CI 1.51, 6.93) times higher compared to their counterparts, respectively.ConclusionThe proportion of mortality among children on ART was high in Ethiopia. Those children who had low CD4 cell count and low hemoglobin levels at baseline need special attention, treatment, and care.Trial registrationThe protocol of this systematic review and meta-analysis has been registered in PROSPERO with the registration number CRD42018113077.

Dataset Information

The performance of BD FACSPresto™ for CD4 T-cell count, CD4% and hemoglobin concentration test in Ethiopia.

Introduction

Methodology

Results

Conclusion

Publications

The performance of BD FACSPresto™ for CD4 T-cell count, CD4% and hemoglobin concentration test in Ethiopia.

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