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PlasmaRef ARN and PlasmaRef ARL-2

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Assay Type

Control Plasmas and Calibrators

Description

Two levels of assayed reference plasmas derived from pooled human plasma.

Intended Use

PlasmaRef ARN is an assayed reference normal plasma for use in the quantitative determination of coagulation proteins.
PlasmaRef ARL-2 is an assayed reference abnormal plasma for use in the quantitative determination of coagulation proteins.

Uses

PlasmaRef ARN is an assayed reference normal plasma for use in the quantitative determination of coagulation proteins.
PlasmaRef ARL-2 is an assayed reference abnormal plasma for use in the quantitative determination of coagulation proteins.

Ordering Information
Catalog # Product Kit Configuration Regulatory Classification Product Insert (PDF)
33-201 PlasmaRef ARN 10 x 1 mL 510(k), CE LL-4513_E-ARN.pdf
35-201 PlasmaRef ARL-2 10 x 1 mL 510(k), CE LL-4515_E-ARL-2.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. PlasmaRef ARN is an assayed reference normal plasma that can be used to construct the standard curves of activity assays, or as a normal plasma validator for such curves. PlasmaRef ARL-2 is used as an abnormal plasma validator for such curves.

The coagulation factor activities of PlasmaRef ARN and ARL-2 are assigned against a freeze dried assayed standard, a fresh frozen normal pool, and, for most analytes, a World Health Organization standard. PlasmaRef ARN and ARL-2 have assigned values for fibrinogen, FII, FV, FVII, FVIII, FIX, FX, FXI, FXII, AT-III (functional), Plasminogen (chromogenic and immunologic), Protein C (chromogenic, clotting, and immunologic), Protein S Total antigen (immunologic), Protein S Free antigen (immunologic), Protein S activity (clotting), and alpha-2 antiplasmin (chromogenic).

PlasmaRef ARN and PlasmaRef ARL-2 are used in factor assays and other tests in the same manner as fresh plasma.

Reporting Units
Handbooks and Guidelines
    • Functional Assays for Factors VIII, IX, XI, XII, Prekallikrein, and HMWK, pages 206-210, and Functional Assays for Factors II, V, VII, and X, pages 210-212, 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.
    • Rogers G, “Testing for Inherited Bleeding Disorders”, 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, KottkeMarchant ed., CAP Press, 2008
    • Kitchen S and Preston F, Chapter 9 “Assays of factor VIII and other clotting factors”, in Quality in Laboratory Hemostasis and Thrombosis, Kitchen, Olson, and Preston ed., Wiley-Blackwell, 2009.
    • Clinical Laboratory Standards Institute, “Determination of Factor Coagulant Activities; Approved Guideline”, CLSI document H48-A, 1997.
    • Clinical Laboratory Standards Institute, “One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline – Second Edition”, CLSI document H47-A2, 2008.

    Related Links

Related Links

Coagulation Factor Assays in the Massachusetts General Hospital Clinical Laboratory Coagulation Test Handbook

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