CLSI Publishes New Guideline for Use of Mass Spectrometry in the Clinical Laboratory.

WAYNE, Pa. -- The development of more user-friendly, affordable, and versatile mass spectrometers, as well as the availability of stable isotopes that serve as internal standards to facilitate more accurate quantification, has allowed a large increase in the use of mass spectrometry (MS) for clinical applications.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published General Principles and Guidelines on the Use of Mass Spectrometry in the Clinical Laboratory; Proposed Guideline (C50-P) to provide accurate and state-of-the-art information and guidance for the appropriate use of MS in the clinical laboratory. It includes guidance, references, and quality assurance markers that will assist with the implementation and correct operation of an MS system for its many applications. Information on maintaining optimum performance, approaches to ensuring accurate and precise mass measurement, verification of methods, quality control of assays within and between instruments, instrument troubleshooting, sample preparation, interpretation of results, and limitations of the technology is included.

The goal of this guideline is to provide a basic understanding of the technology and how it should be used in the clinical laboratory with an emphasis on:

* advantages and disadvantages;

* precautions required in its use;

* quality control awareness;

* assay verification/validation;

* approaches to reporting results; and

* communication of the data.

This document is intended to be a basic resource for clinical chemists; health practitioners; instrument manufacturers; regulatory agencies; and those responsible for developing standards, implementing policy, and teaching. This guideline aims to educate both the practitioners of MS and the medical professionals who will use the results produced by the instruments for the diagnosis, characterization, or monitoring of disease.

The new, proposed guideline was developed by CLSI as part of a partnership effort with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

For additional information on CLSI or for further information regarding this release, visit our website at http://www.clsi.org or call +610.688.0100.

CLSI is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the healthcare and medical-testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.