SEP 09, 2019 8:00 AM PDT

Challenges in hemostasis test standardization

Sponsored by: Diagnostica Stago, Inc.
  • Russell Aaron Higgins, MD

    Medical Director, UHS Pathology Services, University Health System; Professor, Clinical Pathology and Laboratory Medicine, University of Texas Health Science Center at San Antonio


Standardization and harmonization of coagulation testing methods have come a long way in the last 3 to 4 decades; however, standardization is imperfect.  Laboratory professionals need to recognize the limitations of some of our most commonly used coagulation tests.  The INR system has harmonized prothrombin time across methods and platforms for the purpose of monitoring warfarin, but the system does not harmonize very high INR values nor does it harmonize INR values in the setting of liver disease.  Many hospital-based laboratories perform a one stage factor VIII assay to support a wide range of clinical indications.  In the last decade, important biases have been demonstrated between one stage assays and chromogenic assays when diagnosing hemophilia A patients or monitoring new hemophilia therapies.  Finally, quantitative D-dimer assays have excellent negative predictive value to exclude venous thromboembolism.  Unfortunately, there is a lack of standardization, and even a lack of a standardized unit of measure.  Implementation of D-dimer requires careful attention to both the unit of magnitude and the unit type, especially when using different instrumentation across a laboratory system.

Learning Objectives:

  • Recognize limitations of INR system
  • Choose appropriate factor VIII and factor IX assays for various clinical indications
  • Identify potential safety issues created by nonuniform D-dimer units and lack of standardization



LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.  CE credits are available for this webinar up to 2 years from the date of the live broadcast

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SEP 09, 2019 8:00 AM PDT

Challenges in hemostasis test standardization

Sponsored by: Diagnostica Stago, Inc.

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