Performance of the BD FACSPresto near to patient analyzer in comparison with representative conventional CD4 instruments in Cameroon

Sagnia, Bertrand; Ghomsi, Fabrice Mbakop; Gutiérrez, Ana Esteban; Sosso, Samuel Martin; Kamgaing, Rachel; Nanfack, Aubin; Nji, Nadesh; Ambada, Georgia; Lissom, Abel; Tchouangueu, Thibaut Flaurant; Ndengkoh, Loveline Ngu; Domkam, Irenée; Nchinda, Godwin; Ndjolo, Alexis

doi:10.1186/s12981-020-00309-9

Cited by 6 publications

(10 citation statements)

References 23 publications

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“…This study did find variations in the CD4 cell counts test results for the same PLWH samples from different laboratories using POC devices and flow cytometers. However, this observation is consistent with the findings of other studies ( 3 , 13 - 15 ) and may be related to differences in detection principles, laboratory conditions, and/or operators. This suggests that the same institutions with the same machines should be used for follow-up tests on the same patients to provide better stability in evaluating changes in CD4 by avoiding differences caused by devices and personnel, if possible.…”

Section: Discussionsupporting

confidence: 92%

“…The findings indicated a good consistency and relevance between POC devices and flow cytometry test results with correlation coefficients >0.8. Moreover, the consistency was also close to the results reported in other research ( 11 , 13 - 14 ). This study did find variations in the CD4 cell counts test results for the same PLWH samples from different laboratories using POC devices and flow cytometers.…”

Section: Discussionsupporting

confidence: 91%

“…It can ultimately help PLWH get their CD4 count test results faster and facilitate their timely initiation into or adjustment to antiviral treatment regimens (9-10). In some countries, studies have shown that adopting POC CD4 detection instruments can meaningfully improve the timeliness of initiating antiviral therapies (6,(11)(12). Timeliness plays a vital role in the care and therapeutic evaluation of HIV patients; this is especially witnessed in mobile HIV testing services (HTS) delivery, which patients are often more willing to use (11).…”

Section: Discussionmentioning

confidence: 99%

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Assessment of POC CD4 Detecting Mode in District or County Labs — Jiangsu Province, China, 2021

Zhang¹,

Xu²,

Sun³

et al. 2022

China CDC Weekly

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Objective: This study seeks to explore efficient and multiple-item detection modes in new-style HIV labs, as well as access the accuracy and reliability of CD4 cell count detected by point of care (POC) to analyze POC work feasibility in district or county labs.Methods: POC devices adopted in grassroots-level labs and flow cytometers adopted in prefecture-level labs were used to analyze the same group of blood samples. The individual results were collected and compared for parametric tests in correlation and consistency.Results: The Pearson correlation coefficients (r) between results detected by FACSPresto and that by FACSCalibur, FACSVia, FACSCantoII, and EPICSXL were 0.922, 0.938, 0.914, and 0.823, respectively; the average deviations were −25.64, 24.68, 3.05, and 70.97 cells/μL, respectively; the Pearson correlation coefficient (r) between results by Pima and FACSCalibur, FACSVia, FACSCantoII, and EPICSXL were 0.900, 0.950, 0.954, and 0.876, respectively; and the average deviations were −73. 99, −40.78, −29.32, and −22.75 cells/μL, respectively. Discussion: Strong positive correlations and good consistency were observed between the CD4 count tested by POC and flow cytometers. These findings provide theoretical support for new-style HIV labs and one-stop services, which can provide shorter testing duration and simpler testing processes, so that the most comprehensive testing results can be obtained in the shortest amount of time. METHODS Materials and MethodsIn this study, blood samples were collected in China CDC Weekly Chinese Center for Disease Control and Prevention CCDC Weekly / Vol. 4 / No. 47

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

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Assessment of POC CD4 Detecting Mode in District or County Labs — Jiangsu Province, China, 2021

Zhang¹,

Xu²,

Sun³

et al. 2022

China CDC Weekly

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“…The rst study done in Cameroon on the BD FACSPresto performance was published comparing BD FACSPresto versus PIMA, BD FACSCount and BD FACSCalibur. [12]. The CIRCB is a large reference laboratory working under the ISO 15189-2012.…”

Section: Discussionmentioning

confidence: 99%

“…In this context, many pharmaceutical companies proposed new instruments with innovative characteristics like point of care utility able to enumerate only CD4 absolute cell counts like the Abbott PIMA (previously Alere) or CD4 absolute counts and percentages combined with hemoglobin concentration like the FACSPresto from Becton Dickinson [8][9][10]. Many performance comparison studies have been done with the BD FACSCalibur as a validated reference ow cytometry instrument in different countries in Africa [11][12][13][14] or in Asia [15]. To date, there have been no studies published using the validated BD FACSCanto II clinical software to measure the T/B/NK cell populations and other parameters of research and clinical analysis.…”

Section: Introductionmentioning

confidence: 99%

Accurate and Reproducible Enumeration of Cd4 T Cell Counts and Hemoglobin Levels Using a Point of Care System: Comparison With Conventional Laboratory Based Testing Systems in a Clinical Reference Laboratory in Cameroon

Sagnia

Moudourou

GUTIEREZ³

et al. 2022

Preprint

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Background Measurements of CD4 T cells and hemoglobin (Hb) are used to determine the immunological state and information about disease progression for HIV-infected patients. We analyze the correlation in CD4 and Hb measurements using BD FACSPresto™ system compared with the BD validated FACSCanto™ II clinical software analyzer and Sysmex XN 1000 haematology analyzer. We evaluated the advantages of using the POC device in the era of scale up in access for HIV patient management in resource limited settings Method The analytical performance of the BD FACSPresto compared with the FACSCanto II flow cytometer and the Sysmex XN 1000 haematology analyzer was evaluated testing 241 routine clinical specimens collected in EDTA tubes from patients attending the Immunology and Microbiology laboratory of Chantal BIYA International Reference Centre (Yaounde, Cameroon) between January and May 2016. Results The mean in absolute counts and percentage of CD4 T cells was 606 cells/mL and 25% respectfully via the FACSPresto and 574 cells/mL and 24% respectfully via the BD FACSCanto II. The mean concentration of Hb levels was 11.90 on the Sysmex XN 1000 and 11.45 via the BD FACSPresto. A high correlation (R2 = 0.95, P < 0.001) of Hb level measurements was noted between the BD FACSPresto™ and Sysmex XN 1000 hematology analyzer. Overall, Bland-Altman plot of the differences between the two methods showed an excellent agreement for absolute and percentage CD4 counts and hemoglobin measurements between POC and conventional methods evaluated here. Furthermore, the study demonstrated the ease of use of the BD FACSPresto POC technology in remote areas. Conclusion The BD FACPresto is a suitable tool for CD4 enumeration in resource-limited settings, specifically providing a deployable, reliable POC testing option. The BD FACSPresto™ performed appropriately in comparison to the conventional reference standard technologies The BD FACSPresto system provides accurate, reliable, precise CD4/%CD4/Hb results on venous blood sampling. The data showed good agreement between the BD FACSPresto, BD FACSCanto and Sysmex XN 1000 XN 1000 systems.

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Evaluation of a collaborative model for successful implementation of a National CD4 enumeration EQA program in Cameroon

Sagnia

Kiazyk

Meyers

et al. 2021

Sci Rep

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Participation in an EQA program is critical to the quality assurance process. Reliable and precise CD4 T-cells enumeration are essential to improve the clinical management of patients by evaluating the disease progression and by monitoring the effectiveness of ART in HIV-patients. The CIRCB, CD4 reference laboratory, in collaboration with the Canadian QASI-program, recruited sites, distributed and analyzed CD4-panels in 61 sites across Cameroon. A trend and performance analysis in the pre-analytical, analytical and post-analytical phases was performed. Continuous training and corrective actions carried out from 2014 to 2018 increased the number of participating sites from 15 to 61 sites, the number of unacceptable results decreased from 50 to 10%. Specific challenges included errors in pre analytic (17.5%), analytic (77.0%) and post-analytic (5.5%) phases. This EQA requires the application of good laboratory practices, fluidic communication between all the stakeholders, continuous training, application of specific on-site corrective measures, and timely equipment maintenance in order to avoid repetitive errors and to increase laboratory performance. It could be extended to other HIV-1 testing like viral load and EID point-of-care. Partnership with QASI serve as a model for implementation of a successful EQA model for resource limited countries wanting to implement EQA for HIV testing and monitoring in alignment with 90–90–90 targets.

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Performance of the BD FACSPresto near to patient analyzer in comparison with representative conventional CD4 instruments in Cameroon

Cited by 6 publications

References 23 publications

Assessment of POC CD4 Detecting Mode in District or County Labs — Jiangsu Province, China, 2021

Assessment of POC CD4 Detecting Mode in District or County Labs — Jiangsu Province, China, 2021

Accurate and Reproducible Enumeration of Cd4 T Cell Counts and Hemoglobin Levels Using a Point of Care System: Comparison With Conventional Laboratory Based Testing Systems in a Clinical Reference Laboratory in Cameroon

Evaluation of a collaborative model for successful implementation of a National CD4 enumeration EQA program in Cameroon

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