Verification and standardization of blood cell counters for routine clinical laboratory tests

Abstract

The use of automated blood cell counters (automated hematology analyzers) for diagnostic purposes is inextricably linked to clinical laboratories. However, the need for uniformity among the various methods and parameters is increasing and standardization of the automated analyzers is therefore crucial. Standardization not only involves procedures based on reference methods but it also involves validation, verification, quality assurance, and quality control, and it includes the involvement of several participants. This article discusses the expert guidelines and provides an overview of issues involved in complete blood count parameter reference methods and standardization of reporting units.

Keywords: Automated blood cell counter; Clinical hematology laboratory; Hematology analyzers; Standardization; Validation; Verification.