Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published an approved-level document, Analysis of Body Fluids in Clinical Chemistry; Approved Guideline (C49-A). This document provides guidance for clinical diagnostic laboratories to apply widely available measurement procedures to body fluids, as well as for reporting and interpreting those results. Emphasis is placed on:
the common clinical situations for this use;
acceptable practice for measuring analytes without extended method verification for abnormal body fluids;
influence of biologic and analytic variation on interpretation of results;
variability in comparing results between different instrument manufacturers; and
recommended reporting format.
This document does not consider serum, plasma, whole blood, or fluids for which assays typically have performance claims in the measurement procedure documentation.
The new 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.
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