Abstract
BackgroundIn 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.MethodsIn 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.ResultsThe coefficient of determination R2 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 R2 of 0.80 and a mean bias of − 0.12 with a LOA between − 1.75 and 1.51.ConclusionWhen 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.
Highlights
In the era of “test and treat strategy”, CD4 testing remains an important tool for monitoring HIVinfected individuals
Universal access to the treatment has transformed the deadly HIV/AIDS to a chronic disease, in developed countries. They are endeavoring to achieve the UNAIDS goal towards ending the epidemic, by 2030 [10,11,12]. In contrast with this context, the HIV/AIDS remains an important cause of death in resources limited countries, despite significant efforts that aimed at helping these countries access HAART therapy
Morocco is regarded as low HIV prevalence area, since this prevalence is less than 0.1%, and the current estimate of persons living with HIV/AIDS is around 22,000
Summary
In the era of “test and treat strategy”, CD4 testing remains an important tool for monitoring HIVinfected individuals. Once a person tested infected with HIV, they should be offered HAART therapy, immediately and regardless of their CD4 count [9] In this respect, universal access to the treatment has transformed the deadly HIV/AIDS to a chronic disease, in developed countries. They are endeavoring to achieve the UNAIDS goal towards ending the epidemic, by 2030 [10,11,12] In contrast with this context, the HIV/AIDS remains an important cause of death in resources limited countries, despite significant efforts that aimed at helping these countries access HAART therapy. Thanks to these efforts, 24.5 million patients accessed HAART treatment at the end of 2018 [13]. CD4 count remains an essential tool for HIV management for many low-to-middle income countries, mainly in Sub Saharan African countries, that have adopted “test and treat” approach, but its implementation has been challenging [16,17,18]
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