CD4 Lymphocyte Enumeration and Hemoglobin Assessment Aid for Priority Decisions: A Multisite Evaluation of the BD FACSPresto™ System

Thakar, Madhuri; Angira, Francis; Pattanapanyasat, Kovit; Wu, Alan H.B.; O’Gorman, Maurice R.G.; Zeng, Hui; Qu, Chenxue; Mahajan, Bharati; Sukapirom, Kasama; Chen, Danying; Yu, Han‐Qing; Gong, Yan; Indig, Monika de Arruda; Graminske, Sharon; Orta, Diana; d’Empaire, Nicole; Lu, Beverly; Omana-Zapata, Imelda; Zeh, Clement

doi:10.2174/1874613601711010076

Cited by 9 publications

(22 citation statements)

References 35 publications

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“…As far as FACSPresto method concerned, this technology performs well when compared to the reference method, since the mean bias is − 8.1 cells/µl and 0.2%, for absolute count and CD4 percentage, respectively. These findings are in line with previous studies that report similar results [31,32].…”

Section: Discussionsupporting

confidence: 94%

Assessment of two POC technologies for CD4 count in Morocco

et al. 2020

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Background: In the era of "test and treat strategy", CD4 testing remains an important tool for monitoring HIVinfected individuals. Since conventional methods of CD4 count measurement are costly and cumbersome, POC CD4 counting technique are more affordable and practical for countries with limited resources. Before introducing such methods in Morocco, we decided to assess their reliability. Methods: In this study 92 blood samples from HIV-infected patients, were tested by PIMA and FACSPresto to derive CD4 count. Flow cytometry using FacsCalibur, was used as reference method for CD4 count comparison. Linear regression, Bland-Altman analysis were performed to assess correlation and agreement between these POC methods and the reference method. In addition, sensitivity and specificity, positive predictive value (PPV), negative predictive value (NPV) and misclassification percentage at 350 and 200 CD4 count thresholds; were also determined. Finally, because FACSPresto can also measure hemoglobin (Hb) concentration, 52 samples were used to compare FACSPresto against an automated hematology analyzer. Results: The coefficient of determination R 2 was 0.93 for both methods. Bland-Altman analysis displayed a mean bias of − 32.3 and − 8.1 cells/µl for PIMA and FACSPresto, respectively. Moreover, with a threshold of 350 CD4 count,

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Section: Discussionsupporting

confidence: 94%

Assessment of two POC technologies for CD4 count in Morocco

et al. 2020

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“…As far as FACSPresto method concerned, this technology performs well when compared to the reference method, since the mean bias is -8.1 cells/µl and 0.2%, for absolute count and CD4 percentage, respectively. These ndings are in line with previous studies that report similar results [31,32].…”

Section: Discussionsupporting

confidence: 94%

Assessment of two POC technologies for CD4 count in Morocco

Elharti

Abbadi

Bensghir

et al. 2020

Preprint

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Background : In the era of “test and treat strategy”, CD4 testing remains an important tool for monitoring HIV-infected individuals. Since conventional methods of CD4 count measurement are costly and cumbersome, POC CD4 counting technique are more affordable and practical for countries with limited resources. Before introducing such methods in Morocco, we decided to assess their reliability. Methods : In this study 92 blood samples from HIV-infected patients, were tested by PIMA and FACSPresto to derive CD4 count. Flow cytometry using FacsCalibur, was used as reference method for CD4 count comparison. Linear regression, Bland-Altman analysis were performed to assess correlation and agreement between these POC methods and the reference method. In addition, sensitivity and specificity, positive predictive value (PPV), negative predictive value (NPV) and misclassification percentage at 350 and 200 CD4 count thresholds; were also determined. Finally, because FACSPresto can also measure hemoglobin (Hb) concentration, 52 samples were used to compare FACSPresto against an automated hematology analyzer. Results : The coefficient of determination R 2 was 0.93 for both methods. Bland-Altman analysis displayed a mean bias of -32.3 and -8.1 cells/µl for PIMA and FACSPresto, respectively. Moreover, with a threshold of 350 CD4 count, PIMA displayed a sensitivity, specificity, PPV, NPV, were 88.57%, 94.12%, 91.18%, 92.31%; respectively. FACSPresto showed 88.23%, 96.23%,93.75% and 92.73%; respectively. Furthermore, the upward misclassification percentage was 8.57 and 5.88%, for PIMA and FACSPresto, respectively; whereas the downward misclassification percentage was 7.84% and 7.54%; respectively. With 200 cells/µl threshold, PIMA had a sensitivity, specificity, PPV and NPV of 83.33%, 98.53%, 93.75% and 95.71%, respectively. Regarding FACSPresto, sensitivity, specificity, PPV and NPV was 82.35%, 98.57%, 88.57% and 95.83%; respectively. Upward misclassification percentage was 5.56% and 5.88%, for PIMA and FACSPresto, respectively; whereas downward misclassification percentage was 4.41% and 4.29%; respectively. Finally, the hemoglobin measurement evaluation displayed an R 2 of 0.80 and a mean bias of-0.12 with a LOA between -1.75 and 1.51. Conclusion : When compared to the reference method, PIMA and FACSPresto have shown good performance, for CD4 counting. The introduction of such POC technology will speed up the uptake of patients in the continuum of HIV care, in our country.

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“…percentage, respectively. These findings are in line with previous studies that report similar results [27,28].…”

Section: Quality Controlsupporting

confidence: 94%

Assessment of two POC technologies for CD4 count in Morocco

Elharti

Abbadi²,

Bensghir³

et al. 2020

Preprint

View full text Add to dashboard Cite

Background : In the era of “test and treat strategy”, CD4 testing remains an important tool for monitoring HIV-infected individuals. Since conventional methods of CD4 count measurement are costly and cumbersome, POC CD4 counting technique are more affordable and practical for countries with limited resources. Before introducing such methods in Morocco, we decided to assess their reliability. Methods : in this study 92 blood samples from HIV-infected patients, were tested by PIMA to generate absolute CD4 count and by FACSPresto to derive percentage and absolute CD4 count. Flow cytometry using FacsCalibur, was used as reference method for CD4 count comparison. Linear regression, Bland and Altman analysis were performed to assess correlation and agreement between POC methods and the reference method. In addition, sensibility and specificity, positive predictive value (PPV), negative predictive value (NPV) at 350 CD4 count threshold were also determined. Finally, because FACSPresto can also measure hemoglobin (Hb) concentration, 52 samples were used to compare FACSPresto against an automated hematology analyzer. Results : With PIMA technology, the coefficient of determination R 2 was 0.93. Regarding FACSPresto, R 2 was 0.93 and 0.96for absolute CD4 count and percentage CD4 count, respectively. Bland and Altman analysis displayed a mean bias of -32.3 cells/µl with a limit of agreement (LOA): -181.3 to116.8, for Pima. The mean bias for FACSPresto was -8.1 cells/µl with LOA:-158.2 to 142.0for absolute CD4 count and 0.2 with LOA:-3.8 to 4.3, for CD4 percentage. Moreover, with a threshold of 350 CD4 count, sensibility, specificity, PPV, NPV, were 98%, 87%, 89%, 86%, and 88%, 96%,93% and 92% for PIMA and FACSPresto, respectively. Finally, the hemoglobin measurement evaluation displayed an R 2 of 0.80 and a mean bias of-0.12 with a LOA between -1.75 and 1.51. Conclusion : When compared to the reference method, PIMA and FACSPresto have shown good performance, for CD4 counting. The introduction of such POC technology will speed up the uptake of patients in the continuum of HIV care, in our country.

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CD4 Lymphocyte Enumeration and Hemoglobin Assessment Aid for Priority Decisions: A Multisite Evaluation of the BD FACSPresto™ System

Cited by 9 publications

References 35 publications

Assessment of two POC technologies for CD4 count in Morocco

Assessment of two POC technologies for CD4 count in Morocco

Assessment of two POC technologies for CD4 count in Morocco

Assessment of two POC technologies for CD4 count in Morocco

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