Abstract
The CD4+ T cell count estimation is an important monitoring tool for HIV disease progression and efficacy of anti-retroviral treatment (ART). Due to availability of ART at low cost in developing countries, quest for reliable cost effective alternative methods for CD4+ T cell count estimation has gained importance. A simple capillary-based microflurometric assay (EasyCD4 System, Guava Technology) was compared with the conventional flow cytometric assay for estimation of CD4+ T cell counts in 79 HIV infected individuals. CD4+ T cell count estimation by both the assays showed strong correlation (r = 0.938, p < 0.001, 95% CI 0.90 to 0.96). The Bland Altman plot analysis showed that the limits of variation were within agreeable limits of ± 2SD (-161 to 129 cells/mm3). The Easy CD4 assay showed 100% sensitivity for estimating the CD4+ T cell counts < 200 cells/mm3 and < 350 cells/mm3 and 97% sensitivity to estimate CD4+ T cell count < 500 cells/mm3. The specificity ranged from 82 to 100%. The Kappa factor ranged from 0.735 for the CD4+ T cell counts < 350 cells/mm3 to 0.771 for < 500 cells/mm3 CD4+ T cell counts. The system works with a simple protocol, is easy to maintain and has low running cost. The system is compact and generates minimum amount of waste. Hence the EasyCD4 System could be applied for estimation of CD4+ T cell counts in resource poor settings.
Highlights
Three by five initiative by World Health Organization (WHO) has accelerated efforts to provide anti-retroviral treatment (ART) to all those who need it even in the developing world [1]
The CD4+ T cell counts estimated using EasyCD4 System and flow cytometry showed strong correlation (r = 0.938, p < 0.001, 95% CI 0.90 to 0.96)
The sensitivity and specificity of the Easy CD4 assay was calculated for different categories of CD4+ T cell count as < 200, < 350 and < 500 cells/mm3
Summary
Three by five initiative by World Health Organization (WHO) has accelerated efforts to provide anti-retroviral treatment (ART) to all those who need it even in the developing world [1]. The ART programme initiated at this scale would require extensive back up for counseling, laboratory investigations to support initiation and monitoring of ART and clinical management of adverse reactions. Important decisions such as when to start anti-retroviral therapy or prophylaxis for opportunistic infections are dependent on the CD4+ T cell count estimation. In the absence of facilities for viral load assays, CD4+ T cell count estimations is being used for monitoring of anti-retroviral therapy [2]. Providing reliable CD4+ T cell counts has become imperative for success of the HIV care and treatment programme. Flow cytometric estimations give (page number not for citation purposes)
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