CLSI H20 A2 : 2ED 2007

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.