Dataset Information

Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects.

ABSTRACT: This study aimed to compare the performance of the BD FACSPresto system with the conventional standard-of-care technologies for the measurement of absolute CD4 count (AbsCD4), CD4 percentage (CD4%) and total hemoglobin concentration (Hb) in capillary and venous blood samples of HIV-negative and HIV-positive subjects. A total of 1304 participants were included in this prospective cohort study. Both venous and capillary blood samples were analyzed using the BD FACSPresto system and the results were compared against the BD FACSCalibur for enumerating AbsCD4 and CD4% and Sysmex XT-4000i hematology analyzer for determining Hb levels. Method comparison studies were performed using Deming regression and Bland-Altman plots. The Deming regression analyses comparing the accuracy of the BD FACSPresto system with the reference standard technologies demonstrated a significant linear correlation between the AbsCD4, CD4%, and Hb values generated by the two platforms. The 95% CI of the slopes for AbsCD4, CD4%, and Hb levels were 0.94-0.99, 0.99-1.01 and 0.86-0.93, respectively (P?

SUBMITTER: Lu X

PROVIDER: S-EPMC7658244 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects.

Lu Xiaofan X Sun Hanxiao H Li Haicong H Xia Wei W Wu Hao H Chen Daihong D Tan Meiyu M Yu Shijun S Zhang Tong T Sheng Huiming H Zhu Zhaoqin Z

Scientific reports 20201111 1

This study aimed to compare the performance of the BD FACSPresto system with the conventional standard-of-care technologies for the measurement of absolute CD4 count (AbsCD4), CD4 percentage (CD4%) and total hemoglobin concentration (Hb) in capillary and venous blood samples of HIV-negative and HIV-positive subjects. A total of 1304 participants were included in this prospective cohort study. Both venous and capillary blood samples were analyzed using the BD FACSPresto system and the results wer ...[more]

PMID: 33177659

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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:Despite 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.Blood 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.The 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/?L, 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.Overall, 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.

Dataset Information

Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects.

Publications

Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects.

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