The Clinical and Laboratory Standards Institute (CLSI) recently published 'Procedures for the erythrocyte sedimentation rate test; approved standard-fifth edition' (H02-A5).
This document is a revision of the fourth edition of the approved standard (H02-A4), which was published in December 2000.
H02 takes a unifying approach for optimal use of all the current erythrocyte sedimentation rate (ESR) methods and recommends a standardised method using diluted blood, thus revising the standardised method for the ESR.
To this end, the document outlines the necessary details for the performance of this new, standardised method (based on the original methodology of Fahraeus and Westergren) on diluted (1:4) blood specimens for the determination of the ESR.
Quality assurance (QA) and evaluation of other methods to measure the ESR are also described, including procedures for the preparation of a fresh blood reference material for use in the laboratory or manufacturing of ESR devices.
In addition, H02 provides guidance for the validation, verification, QA and quality control of ESR measurement devices or related controls.
The importance of these developments that led to the revision of H02 are described, including technical innovations and semi-automated instruments that were introduced to eliminate or decrease the risk of exposure of laboratory workers to potentially infectious material, such as blood.
The newer procedures are considered less hazardous, primarily because they are either self-contained, or use disposable materials, or both.
The document provides standardised methods to examine these innovations, both for comparability of results to previously employed methods and to ensure, on an ongoing basis, the QA of the results.
H02 is intended for use by manufacturers of ESR devices, end-user clinical laboratories, accrediting organisations and regulatory bodies.
The standard will enable the user of commercial, disposable ESR equipment to ensure that both the test equipment and test procedures are performing adequately.
End-user clinical laboratories will also find guidance for the establishment of working methods for ESR test validation and for QA of their ESR testing methods.
The ESR test is one of the most widely performed laboratory tests and H02 encompasses the latest research and technologies to encourage its effective use.
