WARNING: We do not support Internet Explorer. It is not secure and will not work correctly. Please come back using a newer web browser.

Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 2nd Edition

View Sample Pages

CLSI EP35

Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 2nd Edition

CLSI EP35 provides recommendations for assessing clinically equivalent performance for additional similar-matrix specimen types and suitable performance for dissimilar-matrix specimen types, such that the laboratory does not necessarily need to repeat the full measurement procedure validation for each specimen type. The recommendations in CLSI EP35 apply to both quantitative measurement procedures and qualitative examinations.

Member price:

List Price:
Add to Cart
Log in/sign up to see your price

Details

Chairholder: Marvin Berman, PhD

Date of Publication: March 3, 2025

Order Code PDF: CLSI EP35Ed2E
ISBN Number: 978-1-68440-269-4

Order Code Print: CLSI EP35Ed2
ISBN Number: 978-1-68440-268-7

Edition: Second

Pages: 90

CLSI EP35 Abstract

Clinical and Laboratory Standards Institute EP35—Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures 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 CLSI EP35, developers of laboratory measurement procedures do not necessarily need to repeat the full measurement procedure validation for each specimen type. CLSI EP35 applies to both quantitative measurement procedures and qualitative examinations. CLSI EP35 is useful to developers of commercial and laboratory-developed tests and medical laboratory personnel.

Back to Top