CLSI H54

Procedures for Validation of INR and Local Calibration of PT/INR Systems, 1st Edition

This document describes the use of certified plasmas to enhance performance of the prothrombin time (PT)/International Normalized Ratio (INR) system test; reviews limitations of the INR systems that may occur when a manufacturer-determined ISI is used without local verification or calibration; and provides a rationale for performing local ISI verification with recommendations as to when PT calibration may be indicated. Part I is a detailed, expanded account for manufacturers and Part II is an abbreviated version useful for the clinical laboratory.

This document is available in electronic format only.

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Chairholder: Dorothy M. Adcock, MD

Date of Publication: August 19, 2005

Order Code PDF: CLSI H54AE
ISBN Number: 1-56238-580-1

Order Code Print: print not available

Edition: First

Pages: 64

CLSI H54 Additional Details

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This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of August 2020. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI H54 Abstract

Clinical and Laboratory Standards Institute document H54-A—Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline is one in a series of guidelines that addresses methodology in blood coagulation testing. It is intended to provide guidance for both manufacturers and clinical laboratory personnel responsible for reporting patient INR results. H54 describes the use of certified plasmas to enhance performance of the prothrombin time (PT)/International Normalized Ratio (INR) system test; reviews limitations of the PT/INR system that may occur when a manufacturer-determined ISI is used without local verification or calibration; and provides a rationale for performing local ISI verification with recommendations as to when PT calibration may be indicated. This guideline is published in two parts. Part I provides an expanded account of the subject and Part II is an abbreviated version that may be useful in the clinical laboratory. Methods of calculating local ISI are provided and the procedure for creating a calibration line for direct INR determination is included. In the expanded guideline, the method of certified plasma preparation and method of INR value assignments are also described in detail. This guideline includes a recommended INR range that certified plasmas should cover and recommended number of certified plasmas required for local ISI calibration. A protocol for performing calibration of PT systems is provided. The objective of this guideline is to improve precision and trueness (accuracy) of PT/INR systems and enhance both laboratory standardization and patient care.