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Rationale for using insensitive quality control rules for today's hematology analyzers.

George S Cembrowski¹, B Smith, D Tung

¹Department of Laboratory Medicine and Pathology, University of Alberta Hospital, Edmonton, Alberta, Canada. cembr001@cha.ab.ca

International Journal of Laboratory Hematology

|April 21, 2010

Summary

Automated hematology quality control (QC) requires broader control ranges for today's precise analyzers. New QC rules like 1(3.5s), 1(4s), and 1(4.5s) are recommended to ensure analytical quality and prevent medically unacceptable results.

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Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes

Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes

Published on: March 22, 2022

Area of Science:

Clinical Laboratory Science
Hematology
Quality Control

Background:

Automated hematology analyzers exhibit variable analytical quality and error detection capabilities.
Current quality control (QC) methods may not adequately address the precision of modern instruments.

Purpose of the Study:

To evaluate the intralaboratory performance of Sysmex XE-2100 analyzers using e-Check QC.
To determine appropriate QC rules for ensuring the analytical quality of automated hematology.

Main Methods:

Comparison of median and 15th percentile imprecision of Sysmex XE-2100 analyzers against total allowable error.
Analysis of multiples of imprecision required for detecting medically unacceptable results.

Main Results:

Large multiples of usual imprecision indicate a need for insensitive QC rules with broad control ranges.
Recommended QC rules for highly precise analyzers include 1(3.5s), 1(4s), and 1(4.5s).

Conclusions:

Manufacturers should provide data on usual and poorer instrument imprecision to support expanded QC limits.
Laboratories using less sensitive QC rules should consider acquiring more precise and dependable instrumentation.