REFERENCE STANDARD OVERVIEW USED IN CONTROL OF VACCINES AND BIOLOGICALS

Abstract

The reference standards are used as measures of the value of the test samples. In some cases, the reference standards have the role of evaluating all factors involved in the assays, thereby proving whether the results are valid or not valid. World Health Organization reference standards are provided for the calibration of assays, serve as a global “highest order” measurement standards. Secondary Reference standards are reference standards established by regional or national authorities or by other laboratories; they are calibrated against, and traceable to, the primary World Health Organization materials and are intended for use in routine tests. In Vietnam, secondary reference standards are the national standard used in testing vaccines and biologicals established by the National Institute for Control of Vaccines and Biologicals. In this review study, we analyze and synthesize information related to the concept and classification of National reference standards, general principles when establishing secondary reference standards.