CLSI Publishes New Chemistry Document C49—Analysis of Body Fluids in Clinical Chemistry
Wayne, Pennsylvania, USA—The Clinical and Laboratory Standards Institute has published C49—Analysis of Body Fluids in Clinical Chemistry. This guideline provides guidance to medical laboratories for the appropriate application of measurement procedures for body fluid testing and for reporting results. This guideline primarily focuses on the recommended practice for verification of measurement procedures for measurands in body fluids and is applicable for laboratory testing requests on body fluids that do not have performance claims in the manufacturer’s package insert or an equivalent validated laboratory-developed test.
This guideline replaces the previous edition, published in April 2007. This second edition of C49 provides medical laboratories with a strategy to evaluate method performance, as well as guidance on which measurands have clinical relevance when measured in body fluid matrixes. Several changes were made in this edition.
C49 includes information on:
- Specimen collection and transport.
- Specimen container selection and labeling considerations.
- Body fluid collection and transport specifics.
- Specimen processing.
- Measurement procedure validation.
- Quality assurance.
CLSI sets the standard for quality in medical laboratory testing. A not-for-profit membership organization, CLSI brings together the global laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine.
For nearly 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of medical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve health care around the world.
By using CLSI standards, laboratorians can improve process quality, speed the development of standard operating procedures, and implement safer practices with greater ease and efficiency.