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CLSI EP7 A2 : 2ED 2005

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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INTERFERENCE TESTING IN CLINICAL CHEMISTRY

Superseded date

12-03-2020

Published date

30-04-2018

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
   2.1 Measurement Procedures
   2.2 Concepts and Scientific Principles
3 Standard Precautions
4 Definitions
5 Decision Criteria for Interference Testing
   5.1 Clinical Acceptability Criteria
   5.2 Statistical Significance and Power
   5.3 Analyte Test Concentrations
   5.4 Potential Interfering Substances
   5.5 Interferent Test Concentrations
6 Quality Assurance and Safety
   6.1 Training and Familiarization
   6.2 Precision Verification
   6.3 Trueness Verification
   6.4 Carryover Assessment
   6.5 Quality Control
   6.6 Safety and Waste Disposal
7 Estimation of Interference Characteristics
   7.1 Interference Screen
   7.2 Characterization of Interference Effects
   7.3 Evaluating Combinations of Analyte and
        Interferent(s)
8 Evaluating Interference Using Patient Specimens
   8.1 Experimental Design
   8.2 Comparative Measurement Procedure
   8.3 Patient Populations
   8.4 Experimental Procedure
   8.5 Data Analysis
   8.6 Interpretation of Results
9 Establishing, Validating, and Verifying Interference
   Claims
   9.1 Establishing Interference Claims
   9.2 Verifying Analytical Specificity
   9.3 Validating Analytical Specificity
   9.4 Verifying Interference and Specificity Claims
10 Investigating Discrepant Patient Results
   10.1 Verify System Performance
   10.2 Evaluate Sample Quality
   10.3 Confirm the Original Result
   10.4 Identify Potentially Interfering Substances
   10.5 Determine the Probable Interferent
   10.6 Characterize the Interference
References
Appendix A. Guidelines for Specific Measurement
            Procedures
Appendix B. Analyte Test Concentrations
Appendix C. Interferent Test Concentrations
Appendix D. Interference Test Concentrations for Endogenous
            Analytes
Appendix E. Worksheets
Appendix F. Calculation of Replicates for Dose-Response
            Tests
Appendix G. Preparation of Test Solutions for Interference
            Testing
Summary of Consensus Comments and Committee Responses
Summary of Consensus/Delegate Comments and Committee Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Describes the background information, guidance, and experimental procedures for investigating, identifying, and characterizing the effects of interfering substances on clinical chemistry test results.

DevelopmentNote
Supersedes NCCLS EP7 A. (11/2005)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

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UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
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CLSI MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
BS EN ISO 15197:2015 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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CLSI MM23 : 1ED 2015 MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS)
CLSI QMS24 : 3ED 2016 USING PROFICIENCY TESTING AND ALTERNATIVE ASSESSMENT TO IMPROVE MEDICAL LABORATORY QUALITY
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CLSI NBS05 A : 1ED 2011 NEWBORN SCREENING FOR CYSTIC FIBROSIS
CLSI H59 P : 1ED 2010 QUANTITATIVE D-DIMER FOR THE EXCLUSION OF VENOUS THROMBOEMBOLIC DISEASE
CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
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BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
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CSA ISO 15197 : 2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
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CLSI C53 P : 1ED 2008 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
ISO/TS 17822-1:2014 In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
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DIN EN ISO 18113-1:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
BS EN ISO 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
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PREN ISO 15197 : DRAFT 2011 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
UNE-EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

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CLSI C3 P4 : 4ED 2005 PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY
CLSI HS1 A2 : 2ED 2004 A QUALITY MANAGEMENT SYSTEM MODEL FOR HEALTH CARE
CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES

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