CLSI EP7 A2 : 2ED 2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
03-12-2020
04-30-2018
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)
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| DocumentType |
Miscellaneous Product
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| PublisherName |
Clinical Laboratory Standards Institute
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| CLSI EP19 : 2ED 2015 | A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI EP18 P2 : 2ED 2007 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
| CLSI MM22 A : 1ED 2014 | MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES |
| CLSI EP18 A2 : 2ED 2009 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
| CLSI MM9 A2 : 2ED 2014 | NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE |
| CLSI EP25 A : 1ED 2009 | EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| CLSI EP29 A : 1ED 2012 | EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
| CLSI MM1 A3 : 3ED 2012 | MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING |
| CLSI POCT17 : 1ED 2016 | USE OF GLUCOSE METERS FOR CRITICALLY ILL PATIENTS |
| CLSI EP18 P3 : 3ED 2009 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
| CLSI C51 P : 1ED 2010 | EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
| CLSI C56 A : 1ED 2012 | HEMOLYSIS, ICTERUS, AND LIPEMIA/TURBIDITY INDICES AS INDICATORS OF INTERFERENCE IN CLINICAL LABORATORY ANALYSIS |
| CLSI MM17 P : 1ED 2007 | VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
| CLSI EP27 P : 1ED 2009 | HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR DIAGNOSTIC ASSAYS |
| CLSI H57 A : 1ED 2008 | PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS |
| CLSI MM10 A : 1ED 2006 | GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| PD ISO/TS 17822-1:2014 | <i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions |
| CLSI EP17 A2 : 2ED 2012 | EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| 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) |
| CLSI GP29 A2 : 2ED 2008 | ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE |
| CLSI I/LA32 P : 1ED 2009 | NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY |
| CLSI EP30 A : 1ED 2010 | CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE |
| CLSI POCT6 : 1ED 2015 | EFFECTS OF DIFFERENT SAMPLE TYPES ON GLUCOSE MEASUREMENTS |
| CLSI I/LA20 : 3ED 2016 | ANALYTICAL PERFORMANCE CHARACTERISTICS, QUALITY ASSURANCE, AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E ANTIBODIES OF DEFINED ALLERGEN SPECIFICITIES |
| CLSI MM6 A2 : 2ED 2010 | QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
| CLSI C34 A3 : 3ED 2009 | SWEAT TESTING: SAMPLE COLLECTION AND QUANTITATIVE CHLORIDE ANALYSIS |
| 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 |
| EN ISO 18113-1:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| 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 |
| CLSI I/LA34 A : 1ED 2011 | DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS |
| 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 |
| CLSI C57 : 1ED 2015 | MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM |
| CLSI H57 P : 1ED 2007 | PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS |
| 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 |
| CLSI POCT5 P : 1ED 2008 | PERFORMANCE METRICS FOR CONTINUOUS INTERSTITIAL GLUCOSE MONITORING |
| CSA ISO 15197 : 2015 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| CLSI I/LA33 A : 1ED 2009 | VALIDATION OF AUTOMATED SYSTEMS FOR IMMUNOHEMATOLOGICAL TESTING BEFORE IMPLEMENTATION |
| CLSI NBS04 A : 1ED 2010 | NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY<br> |
| 11/30208525 DC : 0 | BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| I.S. EN ISO 18113-1:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| 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) |
| CLSI H59 A : 1ED 2011 | QUANTITATIVE D-DIMER FOR THE EXCLUSION OF VENOUS THROMBOEMBOLIC DISEASE |
| CLSI EP9 A3 : 3ED 2013 | MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
| CLSI EP22 P : 1ED 2010 | PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES |
| 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 |
| CLSI POCT12 A3 : 3ED 2013 | Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition<br> |
| CLSI GP40 A4 : 4ED 2006 | PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| 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) |
| CLSI C24 A2 : 2ED 99 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENTS: PRINCIPLES AND DEFINITIONS |
| CLSI EP14 A2 : 2ED 2005 | EVALUATION OF MATRIX EFFECTS |
| CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
| 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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