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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

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Superseded date: 12-03-2020

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Published date: 30-04-2018

Publisher: Clinical Laboratory Standards Institute

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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

General Product Information - (Show below) - (Hide below)

Development Note	Supersedes NCCLS EP7 A. (11/2005)
Document Type	Miscellaneous Product
ISBN
Pages
Published
Publisher	Clinical Laboratory Standards Institute
Status	Superseded
Superseded By	CLSI EP07 3ED : 2018
Supersedes	CLSI EP7 A : 1ED 2002

Standards Referenced By This Book - (Show below) - (Hide below)

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	In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro 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
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
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)

Standards Referencing This Book - (Show below) - (Hide below)

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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