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CLSI H20 A2 : 2ED 2007

Current
Current

The latest, up-to-date edition.

Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods, 2nd Edition
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

18-01-2007

Publisher

Clinical Laboratory Standards Institute

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
   2.1 Automated WBC Differential Counters
   2.2 Classification of Automated Devices for WBC
        Differential Counts
   2.3 Limitations
   2.4 Causes of Variability in WBC Counts
3 Standard Precautions
4 Definitions
5 Principles
   5.1 Selection of Reference Method
   5.2 Safety and Effectiveness of Differential Counters
   5.3 Performance Testing
6 Reference WBC Differential Count
   6.1 Specimen Collection
   6.2 Blood Film Preparation
   6.3 Requirements for an Acceptable Blood Film
   6.4 Romanowsky Staining
   6.5 Blood Nucleated Cells Included in the WBC Differential
        Count
   6.6 Protocol for Examining Blood Film
7 Experimental Design
8 Sample Preparation
   8.1 Preparation
   8.2 Labeling
9 Data Collection
   9.1 Performance of Tests
   9.2 Data Acquisition
10 Clinical Sensitivity Study
   10.1 Reference (Normal) Values
   10.2 Sensitivity for Finding Abnormal Samples
11 Data Analysis
   11.1 Comparison of Methods (Inaccuracy)
   11.2 Predictive Value Performance
12 Proposed Reference Method for WBC Differential Counting
   12.1 A Potential Alternative Reference Method
References
Summary of Consensus Comments and Committee Responses
Summary of Delegate Comments and Committee Responses
The Quality System Approach
Related CLSI/NCCLS Publications

These recommendations cover performance testing of leukocyte (WBC) differential counting. Only those WBC found in normal (nondiseased) individuals will be addressed.

These recommendations cover performance testing of leukocyte (WBC) differential counting. Only those WBC found in normal (nondiseased) individuals will be addressed. These cell types are: neutrophils (segmented), neutrophils (band forms), lymphocytes (normal), lymphocytes (variant forms), monocytes, eosinophils, and basophils. If not identified, the system should appropriately flag other cells as abnormal, suspect or unclassified, or as nucleated red blood cells (NRBC).Some devices may group several cell types into a single category. For example, segmented and band neutrophils, eosinophils, and basophils may be combined as granulocytes.

DevelopmentNote
Supersedes NCCLS H20 A. (02/2007)
DocumentType
Standard
ISBN
1-56238-628-X
Pages
76
PublisherName
Clinical Laboratory Standards Institute
Status
Current
Supersedes

CLSI H42 A2 : 2ED 2007 ENUMERATION OF IMMUNOLOGICALLY DEFINED CELL POPULATIONS BY FLOW CYTOMETRY
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17/30341492 DC : 0 BS ISO 20391-1 - BIOTECHNOLOGY - CELL COUNTING - PART 1: GENERAL GUIDANCE ON CELL COUNTING METHODS
CLSI GP44 A4 : 4ED 2010 PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS
CLSI H52 A2 : 2ED 2014 Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition
CLSI H26 A2 : 2ED 2010 VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
CLSI GP42 A6 : 6ED 2008 PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS

CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
CLSI H3 A5 : 5ED 2003 PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
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CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI H26 A : 1ED 96 PERFORMANCE GOALS FOR THE INTERNAL QUALITY CONTROL OF MULTICHANNEL HEMATOLOGY ANALYZERS
CLSI H1 A5 : 5ED 2003 TUBES AND ADDITIVES FOR VENOUS BLOOD SPECIMEN COLLECTION
CLSI H4 A5 : 5ED 2004 PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS
CLSI H18 A3 : 3ED 2004 PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS
CLSI EP10 A3 : 2006 + A1 2014 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES

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PDF - English
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