CLSI EP12 A2 : 2ED 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
Hardcopy , PDF
18-03-2023
English
24-08-2018
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Abstract
Committee Membership
Foreword
Laboratory Error Sources and CLSI Evaluation Protocols
Documents
1 Scope
2 Introduction
3 Standard Precautions
4 Clinical Utility
4.1 Screening Tests
4.2 Diagnostic Tests
4.3 Confirmatory Tests
5 Terminology
5.1 A Note on Terminology
5.2 Terms for Comparative Benchmark
5.3 Definitions
6 Device Familiarization and Training
6.1 Purpose
6.2 Duration
7 Evaluation Materials
7.1 Controls
7.2 Specimen Collection and Handling
8 Bias and Imprecision Studies
8.1 Analyte Concentrations Near the Cutoff
8.2 Negative and Positive Controls
8.3 A Qualitative Method-Precision Experiment for Analyte
Concentrations Near the C[50]
9 Comparison of Methods
9.1 Test Specimens
9.2 Number of Specimens
9.3 Duration
9.4 Inspection of Data During Collection
9.5 Discrepant Results
9.6 Reference Specimen Panels
10 Data Analysis
10.1 Comparator Is Diagnostic Accuracy Criteria
10.2 Comparator Other Than Diagnostic Accuracy Criteria
10.3 Examples
References
Appendix - Statistical Reasoning for Precision Experiment
Conclusions
Summary of Consensus Comments and Working Group Responses
Summary of Delegate Comments and Working Group Responses
The Quality Management System Approach
Evaluation Protocols Documents, Descriptions, and Key Words
Provides a consistent approach for protocol design and data analysis when evaluating qualitative diagnostic tests.
| DevelopmentNote |
Supersedes NCCLS EP12 A. (02/2008)
|
| DocumentType |
Standard
|
| ISBN |
1-56238-654-9
|
| Pages |
64
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| CLSI MM23 : 1ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS) |
| CLSI EP19 : 2ED 2015 | A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI GP29 A2 : 2ED 2008 | ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE |
| CLSI EP18 A2 : 2ED 2009 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
| CLSI EP25 A : 1ED 2009 | EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
| 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 C52 : 3ED 2017 | TOXICOLOGY AND DRUG TESTING IN THE MEDICAL LABORATORY |
| CLSI MM19 A : 1ED 2011 | ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS |
| 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 H60 A : 1ED 2014 | LABORATORY TESTING FOR THE LUPUS ANTICOAGULANT |
| CLSI MM1 A3 : 3ED 2012 | MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING |
| CLSI NBS06 A : 1ED 2013 | NEWBORN BLOOD SPOT SCREENING FOR SEVERE COMBINED IMMUNODEFICIENCY BY MEASUREMENT OF T-CELL RECEPTOR EXCISION CIRCLES |
| CLSI MM22 A : 1ED 2014 | MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES |
| CLSI NBS07 : 1ED 2017 | NEWBORN BLOOD SPOT SCREENING FOR POMPE DISEASE BY LYSOSOMAL ACID A-GLUCOSIDASE ACTIVITY ASSAYS |
| CLSI EP18 P3 : 3ED 2009 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
| CLSI MM3 A3 : 3ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
| CLSI EP27 P : 1ED 2009 | HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR DIAGNOSTIC ASSAYS |
| 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 |
| 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) |
| CLSI MM5 A2 : 2ED 2012 | NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY |
| CLSI I/LA28 A2 : 2ED 2011 | QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS |
| 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 C51 P : 1ED 2010 | EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
| CLSI MM17 A : 1ED 2008 | VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
| 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 QMS01 A4 : 4ED 2011 | QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES |
| CLSI MM19 P : 1ED 2011 | ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS |
| 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 GP37 P : 1ED 2011 | QUALITY MANAGEMENT SYSTEM: EQUIPMENT |
| CLSI MM20 A : 1ED 2012 | QUALITY MANAGEMENT FOR MOLECULAR GENETIC TESTING |
| 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 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 GP16-A3 : 2009 | Urinalysis; Approved Guideline—Third Edition |
| CLSI EP5 A3 : 3ED 2014 | Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition<br> |
| 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 |
| CLSI M24 A2 : 2ED 2011 | SUSCEPTIBILITY TESTING OF MYCOBACTERIA, NOCARDIAE, AND OTHER AEROBIC ACTINOMYCETES |
| 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 EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| 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 |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
| CLSI C24 A3 : 3ED 2006 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
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