CLSI H54 A : 1ED 2005
Current
The latest, up-to-date edition.
PROCEDURES FOR VALIDATION OF INR AND LOCAL CALIBRATION OF PT/INR SYSTEMS
Hardcopy , PDF
English
08-19-2005
Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Definitions
Part I. Detailed Version
4 Laboratory Monitoring of AVK Therapy
4.1 Recommended Method
4.2 Limitations of the INR System
4.3 Optimizing Current PT/INR Test Systems (Prior to
Local Verification or Calibration)
5 Recommendations for Verification of the PT/INR Test
System
5.1 Verification of INR Results
6 Recommendations for Further Improvement of the PT/INR
Test System (INR Calibration)
6.1 PT/INR Calibration
6.2 General Guidelines for the Use of Certified Plasmas
6.3 Frequency of Calibration
6.4 Tissue Factor Species Effects
7 PT/INR System Calibration to Determine Local ISI
7.1 Procedure for Local ISI (ISI[LS] Determination)
7.2 Number of Certified Plasmas Required for Local ISI
Calibration
7.3 Local System Verification Following ISI Calibration
7.4 Criteria for Acceptance of Locally Calculated ISI
7.5 Interpretation of Patient Test Results
8 PT/INR System Calibration to Determine Direct INR
8.1 Recommended Number and Preparation of Certified
Plasmas
8.2 Procedure for Preparation of a Direct INR Calibration
Line
8.3 Interferences
8.4 Guidelines for Determining Result Acceptance
8.5 Interpretation of Patient Test Results
9 Choice of Verification/Calibration Material
9.1 Method of Preparation of Certified Reference
Materials
9.2 Validation of Certified Plasmas
9.3 Documentation Required by Manufacturers
Part II. Abbreviated Version for Laboratorians
10 Introduction
10.1 Limitations of the INR System
10.2 ISI Value Assigned by the Manufacturer
10.3 Thromboplastin/Instrument Interaction
10.4 Components of INR Determination
11 Optimizing the Local PT/INR Test System
11.1 Prothrombin Time
11.2 Mean Normal Prothrombin Time
11.3 Thromboplastin Reagent With a Generic ISI
11.4 Thromboplastin Reagent With an Instrument/
Reagent-Specific ISI
11.5 Use of Good Laboratory Practices
12 Recommendations for Verification of the Local Test
System
12.1 Verification of INR Results
13 Local System Calibration
13.1 General Guidelines for the Use of Certified
Plasmas
13.2 Procedure for Calculating Local ISI
13.3 Procedure for Establishing Direct INR (Locally)
13.4 Interpretation of Patient Test Results
References
Appendix A. Determination of the Geometric Mean Normal
Prothrombin Time (MNPT)
Appendix B. Calculations for Local ISI Determination and
Direct INR Calibration Line
Appendix C. INR Verification, ISI Calibration, and Direct
INR Calibration Line Preparation Using Certified
Plasmas
Summary of Consensus/Delegate Comments and Subcommittee Responses
The Quality System Approach
Related CLSI/NCCLS Publications
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.