CLSI EP10 A3 : 2006 + A1 2014

Name: CLSI EP10 A3 : 2006 + A1 2014
Brand: CLSI
Price: 273.60 USD

Superseded

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PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES

Available format(s)

Hardcopy , PDF

Superseded date

11-28-2019

Language(s)

English

Published date

08-24-2018

Publisher

Clinical Laboratory Standards Institute

Abstract
Committee Membership
Summary of Changes in EP10 Amendment
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Materials
6 Calibration and Sequence of Samples in a Run
7 Number of Days and Runs
8 Preliminary Procedures
9 Collection and Recording of Data
10 Initial Data Plotting and Inspection
11 Analysis of the Data for Imprecision
12 Preliminary Assessment of Bias
13 Full Data Analysis Procedures
14 An Alternative Procedure
15 Use of EP10 by Manufacturers
16 How to Perform Multiple Regression for EP10
References
Symbols Used in Appendixes
Appendix A - Preliminary Performance Acceptability Check
Appendix B - Example Use of Data Sheets
Appendix C - Statistical Explanation
The Quality System Approach
Evaluation Protocols Documents, Descriptions, and Key Words

Before starting a complete evaluation of a new measurement procedure, kit, or instrument for in vitro diagnostic use, it is often necessary to make a preliminary decision about its acceptability.

DevelopmentNote	Supersedes NCCLS EP10 A2. (11/2006) 2006 Edition Re-Issued in May 2014 & incorporates AMD 1 2014. (05/2014)
DocumentType	Miscellaneous Product
ISBN	1-56238-622-0
Pages	70
PublisherName	Clinical Laboratory Standards Institute
Status	Superseded
SupersededBy	CLSI EP10 A3 : 2006/AMD:2014(R2019)
Supersedes	CLSI EP10 A2 : 2ED 2002

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CLSI H48 : 2ED 2016	DETERMINATION OF COAGULATION FACTOR ACTIVITIES USING THE ONE-STAGE CLOTTING ASSAY
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
CLSI EP29 A : 1ED 2012	EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
CLSI POCT12 A3 : 3ED 2013	Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition<br>
CLSI POCT7 A :2010(R2018)	Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection
CLSI EP18 P3 : 3ED 2009	RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
CLSI H26 P2 : 2ED 2009	VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
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 C52 A2 : 2ED 2007	TOXICOLOGY AND DRUG TESTING IN THE CLINICAL LABORATORY
CLSI GP34 P : 1ED 2009	VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION
CLSI I/LA32 P : 1ED 2009	NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
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CLSI MM19 P : 1ED 2011	ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
CLSI NBS05 A : 1ED 2011	NEWBORN SCREENING FOR CYSTIC FIBROSIS
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CLSI H57 P : 1ED 2007	PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
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CLSI MM19 A : 1ED 2011	ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
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CLSI QMS01 A4 : 4ED 2011	QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
CLSI GP34 A : 1ED 2010	VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION
CLSI GP16-A3 : 2009	Urinalysis; Approved Guideline—Third Edition
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CLSI I/LA20 A2 : 2ED 2009	ANALYTICAL PERFORMANCE CHARACTERISTICS AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E (IGE) ANTIBODIES AND DEFINED ALLERGEN SPECIFICITIES
CLSI EP22 P : 1ED 2010	PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES
CLSI C50 A : 1ED 2007	MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE