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Establishment of reference CD4+ T cell values for adult Indian population
Madhuri R Thakar1, Philip R Abraham, Sunil Arora
1Department of Immunology, National AIDS Research Institute, G-73, MIDC, Bhosari, Pune, 411026, India. mthakar@nariindia.org.
Insights
This study established national reference ranges for CD4+ T cell counts in India. These ranges are crucial for monitoring HIV disease progression and antiretroviral therapy effectiveness.
Area of Science:
- Immunology
- Public Health
- Clinical Diagnostics
Background:
- CD4+ T lymphocyte counts are vital for tracking HIV progression and treatment efficacy, especially in resource-limited settings.
- India lacked established nationwide reference ranges for CD4+ T lymphocytes.
- This study aimed to define these essential reference values for the adult Indian population.
Purpose of the Study:
- To determine the reference values for absolute CD4+ T cell counts and percentages in healthy adults across India.
- To establish a national standard for CD4+ T cell measurements to aid in HIV management.
Main Methods:
- A multicentric study involving 1206 healthy participants across eight Indian sites.
- Standardized CD4+ T cell counts and percentages were measured using a single platform, lyse no wash technique.
- Data analysis was performed using SPSS and Prism software.
Main Results:
- Significant differences in CD4+ T cell counts and percentages were observed between males and females.
- Established reference ranges for absolute CD4 counts: 381-1565 cells/μL (males) and 447-1846 cells/μL (females).
- Established reference ranges for CD4%: 25-49% (males) and 27-54% (females).
Conclusions:
- Robust national reference ranges for CD4+ counts and percentages were established using stringent quality control.
- These reference ranges will significantly aid in staging HIV disease and monitoring antiretroviral therapy in India.
Background:
CD4+ 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.
Methods:
A 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.
Results:
The 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.
Conclusion:
The 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.
