Non-transference of biological reference interval of TSH by electrochemiluminescence immunoassay: An Indian population perspective

摘要

Introduction: Although TSH measurement by electrochemiluminescence immunoassay has become commonplace in India, significant discrepancy has been observed on interpretation of the test results when the manufacturer supplied biological reference interval (BRI) criteria were applied. This report determined whether the manufacturer's BRI (Roche Cobas) is transferable to the Indian population. Methods: Three hundred seventy-eight age- and sex-matched healthy subjects were selected from an urban Indian population. TSH reference measurements were acquired, and the reference data were statistically analysed. Results: BRI of the Indian urban reference population was determined by non-parametric means. BRI was found to be 1.134 to 7.280. μIU/ml. Conclusion: BRI thus calculated was found to be significantly different from that mentioned by the manufacturer (0.27 to 4.20. μIU/ml), which, needless to mention, has profound clinical implications in this part of the globe.