RESUMO
Background: Even though several factors affect reference intervals (RIs), company-derived values are currently in use in many laboratories worldwide. However, few or no data are available regarding serum proteins RIs, especially in resource-limited countries such as Ethiopia. Objective: To establish RIs for serum protein electrophoresis of apparently healthy adults in Addis Ababa, Ethiopia. Methods: A cross-sectional study was conducted on a total of 297 apparently healthy adults from April to October 2019 in four selected sub-cities (Akaki, Kirkos, Arada, and Yeka) of Addis Ababa, Ethiopia. Laboratory analysis of collected samples was performed using the Capillarys 2 Flex Piercing analyzer, while statistical analysis was conducted using SPSS version 23 and Med-Calc software. The Mann-Whitney test was used to check partitions. A non-parametric method of reference range establishment was performed as per CLSI guideline EP28A3C. Results: The established RIs were: albumin 53.83-64.59%, 52.24-63.55%; alpha-1 globulin 3.04-5.40%, 3.44-5.60%; alpha-2 globulin 8.0-12.67%, 8.44-12.87%; and beta-1 globulin 5.01-7.38%, 5.14-7.86%. Moreover, the albumin to globulin ratios were 1.16-1.8 and 1.09-1.74 for males and females, respectively. The combined RIs for beta-2 globulin and gamma globulin were 2.54-4.90% and 12.40-21.66%, respectively. Conclusion: The established reference interval for serum protein fractions revealed gender-specific differences, except for beta-2 globulin and gamma globulin.
RESUMO
Background: Reference intervals for clinical laboratory parameters differ based on several factors, including age, sex, genetic variation, and geographic location. This variation influences clinical decisions and treatment monitoring. Currently, Ethiopia has used adopted reference intervals from manufacturer values derived from non-Africans. Therefore, the aim this study was to determine reference intervals for absolute and percentage CD4+ T cells for an apparently healthy population in Addis Ababa, Ethiopia. Methods: A community-based cross-sectional study was conducted on 361 apparently healthy people in four subcities in Addis Ababa from January to June 2019. Sociodemographic and clinical data were collected using a structured questionnaire after informed consent had been obtained. Blood samples were collected and CD4+ T-lymphocyte enumeration performed using a BD FACSPresto near-patient CD4 counter. Data were entered and analyzed using SPSS 20. Reference intervals were determined by a nonparametric test estimating percentiles 2.5 (lower limit) and 97.5 (upper limit) with 95% CIs. P<0.05 was considered statistically significant. Results: A total of 337 (183 female and 154 male) healthy participants of median age 28 (IQR 17-35) years were included in the final analysis. Medians of absolute and percentage CD4+ T-cell counts (932.0 and 42.9, respectively) of female participants were significantly higher than male participants (802.5 and 38.7, respectively; P<0.05). Reference intervals for absolute CD4+ T-cell count and percentages in males were 483.8-1,310 cells/µL and 18.1-57.3 and in females 447.8-1,479.8 cells/µL and 25.6-58.9, respectively. Conclusion: The CD4+ T-count reference intervals established in this study showed some inconsistency from the manufacturer's provided values and other studies and also revealed sex differences, necessitating sex-specific locally established reference intervals.
