Standard Document
Second Edition
Hematology

CLSI H30

Procedure for the Determination of Fibrinogen in Plasma

This document provides a practical and precise approach to performing fibrinogen assays using the Clauss method. It outlines key preanalytical and analytical factors to ensure accurate and reliable results in clinical laboratories.

November 01, 2001
Charles F. Arkin, MD

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Abstract

Clinical and Laboratory Standards Institute document H30-A2—Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline—Second Edition is a performance guideline for laboratory and/or clinical healthcare professionals responsible for the routine performance of fibrinogen assays. This guideline describes a technique, based on the method described by Clauss,1 that is practical, precise, and widely used in the clinical laboratory. Preanalytical and analytical factors and conditions that may alter results are discussed.

Scope
H30-A2 contains guidelines for the collection, transportation, handling, and storage of blood specimens or plasma samples and general guidelines for performing the fibrinogen assay by the Clauss method. It is primarily directed toward laboratory and/or clinical personnel responsible for obtaining and processing blood specimens, performing the fibrinogen assay and quality control procedures, and reporting fibrinogen assay results. It is also intended as a guide for manufacturers of the reagents and instruments. The guideline does not cover prothrombin-time (PT)-derived fibrinogen determination which can be performed using various automated coagulation instruments.
Product Details
H30A2E
1-56238-439-2
16
Additional Details

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

This document is available in electronic format only.

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

Authors
Charles F. Arkin, M.D
Dorothy M. Adcock, M.D.
H. James Day, M.D.
James J. Carroll, Ph.D.
J. Heinrich Joist, M.D., Ph.D.
Jane G. Lenahan
Richard A. Marlar, Ph.D.
Douglas A. Triplett, M.D.
Abstract

Clinical and Laboratory Standards Institute document H30-A2—Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline—Second Edition is a performance guideline for laboratory and/or clinical healthcare professionals responsible for the routine performance of fibrinogen assays. This guideline describes a technique, based on the method described by Clauss,1 that is practical, precise, and widely used in the clinical laboratory. Preanalytical and analytical factors and conditions that may alter results are discussed.

Scope
H30-A2 contains guidelines for the collection, transportation, handling, and storage of blood specimens or plasma samples and general guidelines for performing the fibrinogen assay by the Clauss method. It is primarily directed toward laboratory and/or clinical personnel responsible for obtaining and processing blood specimens, performing the fibrinogen assay and quality control procedures, and reporting fibrinogen assay results. It is also intended as a guide for manufacturers of the reagents and instruments. The guideline does not cover prothrombin-time (PT)-derived fibrinogen determination which can be performed using various automated coagulation instruments.
Additional Details

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

This document is available in electronic format only.

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

Authors
Charles F. Arkin, M.D
Dorothy M. Adcock, M.D.
H. James Day, M.D.
James J. Carroll, Ph.D.
J. Heinrich Joist, M.D., Ph.D.
Jane G. Lenahan
Richard A. Marlar, Ph.D.
Douglas A. Triplett, M.D.