Abstract

Clinical examination has become an important method of disease diagnosis, curative effect evaluation, prognosis judgment and health monitoring, and the biological reference interval is the reference standard to interpret test results and analyses of test information. In clinical tests, the reference interval is often affected by race, sex, age, geographical location and growth and development, so it is very important to establish a suitable reference interval for each laboratory. It is a huge and arduous task for each laboratory to establish its own reference interval. It is unrealistic for different measurement systems to establish reference intervals. According to the C28-A3c guideline from the Clinical and Laboratory Standards Institute (CLSI), clinical laboratories can appropriately transfer the reference intervals provided by other laboratories. This paper reviews whether the biomarkers in multiregional laboratories can transfer reference intervals between different measurement systems to expand the application of reference interval databases and ensure the accuracy and consistency of the test results.

摘要

临床检查已成为疾病诊断、疗效评价、预后判断和健康监测的重要方法，而生物学参考区间是解读检测结果和分析检测信息的参考标准。在临床试验中，参考区间往往受种族、性别、年龄、地理位置和生长发育的影响，因此为每个实验室建立合适的参考区间非常重要。每个实验室建立自己的参考区间是一项艰巨而艰巨的任务。不同的测量系统建立参考区间是不现实的。根据临床和实验室标准协会 (CLSI) 的 C28-A3c 指南，临床实验室可以适当转移其他实验室提供的参考区间。本文回顾了多区域实验室的生物标志物是否可以在不同测量系统之间传递参考区间，以扩大参考区间数据库的应用，确保检测结果的准确性和一致性。