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Assay Type

Control Plasmas and Calibrators

Description

Fibrinogen Reference Plasma

Intended Use

FIB Calibrator is intended for use as a normal reference standard for routine fibrinogen quantitation on citrated plasma.

Uses

FIB Calibrator may be used to generate a standard reference curve for fibrinogen determination or as a quality control check for stored reference curves in daily fibrinogen testing

Ordering Information
Catalog # Product Kit Configuration Regulatory Classification Product Insert (PDF)
71-201 Fib Calibrator 10 x 1 mL 510(k), CE LL-4523_D-FIBCAL.pdf

 

Principle of the Test

 

Fresh pooled normal plasma or assayed reference normal plasma is necessary to construct the standard curve(s) in assay(s) that quantify the activity of coagulation factor(s) in patient plasmas. Fib Calibrator can be used to construct the standard curves of fibrinogen assays.

Fib Calibrator is used in fibrinogen assays in the same manner as fresh plasma.

Reporting Units

 

Handbooks and Guidelines

 

  • Fibrinogen Assays, pages 215-219, in Lapasota et. al., The Clinical Hemostasis Handbook, Year Book Medical Publishers, 1989.  This handbook is no longer in print, but many pathologists have a copy.  Hyperlink to CHH-Fibrinogen-Clauss.pdf.
  • Rogers G, Chapter 5 “Hemostasis Screening Assays”, in Laboratory Hemostasis: A Practical Guide for Pathologists, Bennet S et. al. editors, Springer 2007.
  • Krishnan J, Chapter 6, “Coagulation Testing”, in An Algorithmic Approach to Hemostasis Testing, Kottke‑Marchant ed., CAP Press, 2008
  • Clinical Laboratory Standards Institute, “Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline – Second Edition“, CLSI document H30-A2, 2001.
Related Links

 

Fibrinogen assay in the Massachusetts General Hospital Clinical Laboratory Coagulation Test Handbook

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