Abstract
BackgroundCD4+ T lymphocyte counts are the most important indicator of disease progression and success of antiretroviral treatment in HIV infection in resource limited settings. The nationwide reference range of CD4+ T lymphocytes was not available in India. This study was conducted to determine reference values of absolute CD4+ T cell counts and percentages for adult Indian population.MethodsA multicentric study was conducted involving eight sites across the country. A total of 1206 (approximately 150 per/centre) healthy participants were enrolled in the study. The ratio of male (N = 645) to female (N = 561) of 1.14:1. The healthy status of the participants was assessed by a pre-decided questionnaire. At all centers the CD4+ T cell count, percentages and absolute CD3+ T cell count and percentages were estimated using a single platform strategy and lyse no wash technique. The data was analyzed using the Statistical Package for the Social Scientist (SPSS), version 15) and Prism software version 5.ResultsThe absolute CD4+ T cell counts and percentages in female participants were significantly higher than the values obtained in male participants indicating the true difference in the CD4+ T cell subsets. The reference range for absolute CD4 count for Indian male population was 381-1565 cells/μL and for female population was 447-1846 cells/μL. The reference range for CD4% was 25-49% for male and 27-54% for female population. The reference values for CD3 counts were 776-2785 cells/μL for Indian male population and 826-2997 cells/μL for female population.ConclusionThe study used stringent procedures for controlling the technical variation in the CD4 counts across the sites and thus could establish the robust national reference ranges for CD4 counts and percentages. These ranges will be helpful in staging the disease progression and monitoring antiretroviral therapy in HIV infection in India.
Highlights
CD4 + T lymphocytes play a central regulatory role in the immune response
Some of the recent studies have shown that the treatment at higher CD4+ T cell numbers may be beneficial in reducing the clinical events and death
The comparison of the published data on the CD4+ T cells count in healthy Indian adult population and other parts of the world showed that the CD4+ T cell counts differ with the population, suggesting that each population should have its own reference range for lymphocyte subsets [12]
Summary
CD4 + T lymphocytes play a central regulatory role in the immune response. The decrease in CD4+ T cell numbers can compromise the normal immune functions of the body. It is important to determine the reference CD4+ T cell values to ensure that ART is not initiated when CD4+ T cell counts are in normal range, in case the threshold is increased further. No such ranges are available for Indian population based on a multi-centric well designed study. One study presented data with adequate sample size that included populations from different parts of the country, this study established only the reference range for CD4+ T cell percentages and not for absolute counts [11]. This study was conducted to determine reference values of absolute CD4+ T cell counts and percentages for adult Indian population
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