Reference interval transference of common clinical biomarkers

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.

Keywords: Reference interval; bias; biomarker; measurement system; transference.