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OBJECTIVES: Clinical biochemistry reference intervals (RIs) play a crucial role in interpreting patient test results and making informed clinical decisions. Using data from an ongoing Indian Council of Medical Research-National task force study on healthy women, normative ranges for commonly analyzed biochemical analytes were established. MATERIALS AND METHODS: A total of 13,181 women of reproductive age (18-40 years) were recruited from different urban and rural regions of the country, of which 9898 women signed an informed consent were included. Among these, women having features of hyperandrogenism, menstrual cycle irregularities, and comorbidities were excluded. RIs of 22 analytes were computed in the remaining 938 women controls. To estimate the 95% range of the reference distribution, the limits of the 2.5th percentile and the 97.5th percentile were used in the study. RESULTS: Mean ± standard deviation of age and body mass index of participants was 30.12 ± 6.32 years and 22.8 ± 3.36 kg/m2 respectively. Centiles (2.5th-97.5th) of liver function parameters, lipid parameters, glycaemic parameters, and renal parameters are presented. No significant difference in analytes was observed in relation to the area of residence, and age groups except in albumin (P = 0.03). The distribution of most of the parameters was consistent with the various RI studies conducted in India as well as other countries. CONCLUSION: This is the first study generating biochemical RIs data among a large representative sample of healthy reproductive-age women recruited using a robust design across the country. The resource may serve as a reference range for common biochemical analytes for future in this age group. [ABSTRACT FROM AUTHOR]

Objectives: Clinical biochemistry reference intervals (RIs) are essential benchmarks to interpret patient test results and make clinical decisions. In this study, data on healthy women collected in an ongoing ICMR-National task force study was used to establish normative ranges for common biochemical analytes. Methods: A total of 13,181 women of reproductive age (18-40 years) were recruited from different urban and rural regions of the country, of which 9,898 women who signed an informed consent were included. Among these, women having features of hyperandrogenism, menstrual cycle irregularities, and with comorbidities were excluded. RIs of 22 analytes were computed in remaining 938 women controls. The 95% of the reference distribution was estimated using 2.5th percentile and 97.5th percentile limits. Results: The mean ± SD of age and body mass index (BMI) of participants was 30.12 ± 6.32 years and 22.8 ± 3.36 kg/m2 respectively. The median and 2.5th -97.5th percentiles of liver function parameters, lipid parameters, glycaemic parameters, and renal parameters were computed. No significant difference in analytes were observed in relation to the area of residence, and age groups except in albumin (p = 0.03). The distributions for most of the parameters were consistent with the various reference interval studies conducted in India as well as other countries. Conclusion: This is the first study generating biochemical RIs data among a large representative sample of healthy reproductive age women recruited using a robust design across the country. The resource may serve as reference range for common biochemical analytes for future in this age group. [ABSTRACT FROM AUTHOR]