Wayne, Pennsylvania, USA-June 2011-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. Of significant note, H02 takes a unifying approach for optimal use of all the current erythrocyte sedimentation rate (ESR) methods and recommends a standardized method using diluted blood, thus revising the standardized method for the ESR.
To this end, the document outlines the necessary details for the performance of this new, standardized method (based on the original methodology of Fåhraeus 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.
"This document was revised to incorporate new technologies and a new reference method," said Josep M. Jou, MD, PhD, Senior Consultant, Servei Hemoterapia i Hemostasia Hospital Clinic, from the University of Barcelona in Barcelona, Spain, chairholder of the working group that revised the document. "It defines the current clinical applications and changes in the reference method as well as provides information on how to evaluate the reference method for accuracy."
The importance of these developments that led to the revision of H02 are described, including technical innovations and semiautomated 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 standardized 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.
"This document is important because universally recognized guidelines help promote awareness and best practices, and keep those interested in procedures for ESR up-to-date," said Chiara Derioni, Resp. Servizio Scientifico, Scientific and Technical Service, from Alifax spa in Polverara, Italy, who also contributed to the revision of H02. "The document will thus contribute to both clinical laboratories and ESR instrument manufacturers, not only because of the ESR test itself, but also owing to the new, updated selection of scientific references."
H02 is intended for use by manufacturers of ESR devices, end-user clinical laboratories, accrediting organizations, 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 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.
CLSI is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, and the health care professions. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.