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 CLSI Publishes New Method Evaluation Document


Wayne, Pennsylvania, USAThe Clinical and Laboratory Standards Institute (CLSI) has published the first edition of EP35—Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures. EP35 provides information for assessing clinically equivalent performance for additional similar-matrix specimen types and suitable performance for dissimilar-matrix specimen types. During development, medical laboratory measurement procedures are typically validated for the most common specimen type. However, it can be clinically useful to test the measurand in multiple specimen types, including different fluids (eg, serum, plasma, whole blood, urine, cerebrospinal fluid, saliva), anticoagulants, and collection devices. By following the recommendations in this guideline, developers of laboratory measurement procedures do not necessarily need to repeat the full measurement procedure validation for each specimen type.

EP35 applies to both quantitative measurement procedures and qualitative examinations. This guideline is useful to developers of commercial and laboratory-developed tests and medical laboratory personnel.

The clinical information provided in EP35 is key to establishing equivalent or suitable performance for multiple specimen types, and includes:

  • The expected interval of measurand concentrations. 
  • Inherent biological variability.
  • Medical decision levels.

For more information about EP35 and to view sample pages, click here. 

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 over 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.


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