Enhanced standardization of the International Normalized Ratio through the use of plasma calibrants: a concise review.

The INR was introduced in 1983 as a means of standardizing the prothrombin time test and improving management of patients receiving warfarin-based oral anticoagulant therapy. Despite the eventual widespread use of the INR system, unacceptable levels of inter-laboratory variation persist. The use of certified plasma calibrants has been studied as a means to reducing INR variation. This review examines the pre-analytical and analytical variables contributing to INR problems. Also, the findings of several multicenter studies in which plasma calibrants were deployed are presented. Issues such as the number of calibrants used and their composition, calibrant format, plasma citrate concentration, reference thromboplastins used, methods of calibrant certification and alternative techniques for local system calibration are examined. The development of consensus guidelines on the use of plasma calibrants for INR standardization is recommended.