CLSI H48

Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay, 2nd Edition

Quantitative assays for measuring coagulant activity are important laboratory tools. Enhance the precision and accuracy of patient clotting factor assay results with H48.

This document is available in electronic format only.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of August 2020. The document’s next scheduled review is generally five years after the reaffirmation date.

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Chairholder: Donna D. Castellone, MS, MT(ASCP)SH

Date of Publication: March 30, 2016

Order Code PDF: CLSI H48Ed2E
ISBN Number: 1-56238-931-9

Order Code Print: print not available

Edition: Second

Pages: 60

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CLSI H48 Abstract

Clinical and Laboratory Standards Institute guideline H48—Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay provides information to be used in harmonizing laboratory testing of factor assays. It provides laboratories with guidelines to optimize factor assay testing by minimizing the effect of variation in preexamination, examination, and postexamination processes. It identifies good laboratory practices related to analyzer and reagent performance, reference intervals, lot-to-lot validation, quality assurance, and quality control issues. Standardizing assay performance provides patients with the best outcomes with regard to both diagnosis and treatment. This guideline is written for laboratorians and/or diagnostic testing personnel responsible for factor assay testing, physicians (eg, hematologists, pathologists) responsible for interpreting results, external quality assessment programs, and manufacturers of factor assay testing reagents and test systems.