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CLSI H48

Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay

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Organization: CLSI
Publication Date: 1 March 2016
Status: active
Page Count: 60
scope:

This guideline provides specifications for the one-stage clotting factor assay. It is intended to increase the diagnostic usefulness of the one-stage factor assay by providing the laboratory with necessary tools to minimize the effects of variables and to provide guidelines to enhance the precision and accuracy of patient results. Preexamination, examination, and postexamination issues specific to factor activity testing are covered.

This guideline is written for laboratory and/or diagnostic testing personnel responsible for factor assay testing including the performance, QC, and reporting of assays of coagulation factor activity, physicians (eg, hematologists, pathologists) responsible for interpreting results, external quality assessment (EQA) programs, and manufacturers of factor assay testing reagents and test systems.

This guideline does not cover chromogenic, two-stage clotting, antigenic, or manual methodologies for factor assays. Assays for fibrinogen, von Willebrand Factor (VWF), Factor XIII (FXIII), or contact factors of high molecular weight kininogen or prekallikrein are not covered in this guideline. Assays used to quantify inhibitors to specific factors are not covered in this guideline.

Document History

CLSI H48
March 1, 2016
Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay
This guideline provides specifications for the one-stage clotting factor assay. It is intended to increase the diagnostic usefulness of the one-stage factor assay by providing the laboratory with...
March 1, 2016
Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay
This guideline provides specifications for the one-stage clotting factor assay. It is intended to increase the diagnostic usefulness of the one-stage factor assay by providing the laboratory with...
April 1, 1997
Determination of Factor Coagulant Activities; Approved Guideline
This document provides general recommendations for assaying the coagulant activity of all of the intrinsic, extrinsic, and common coagulation factors except fibrinogen. It confines itself to...

References

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