Harmonizing the International Normalized Ratio (INR) : Standardization of Methods and Use of Novel Strategies to Reduce Interlaboratory Variation and Bias

American Journal of Clinical Pathology
Emmanuel J FavaloroNaomi Hocker

Abstract

To reduce interlaboratory variation and bias in international normalized ratio (INR) results, as used to monitor patients receiving vitamin K antagonist therapy, including warfarin, in a large pathology network (n = 27 laboratories) by procedural standardization and harmonization. Network consensus to standardize to common instrument and reagent platforms was established, following development of hemostasis test specifications. Subsequent installations and implementation occurred after conclusion of a government tender process. Network-wide application of simple novel process of verification harmonization of local international sensitive index and mean normal prothrombin time initiated for each new lot of INR reagent that does not require ongoing use of reference thromboplastin or calibration/certified plasma sets. We achieved reduction of different instrument manufacturers (from four to one), instrument types (10 to three), reagent types (four to one), and instrument/reagent combinations (12 to three), plus substantial reduction in INR variability and bias. Results infer significant improvement in local patient management, with positive implications for other laboratories. For the United States in particular, lack of US Food a...Continue Reading

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Aug 31, 2004·Journal of Thrombosis and Haemostasis : JTH·S A Smith, J H Morrissey
Apr 26, 2006·Journal of Thrombosis and Haemostasis : JTH·S A SmithJ H Morrissey
Dec 17, 2008·Seminars in Thrombosis and Hemostasis·Emmanuel J Favaloro, Dorothy M Adcock
Apr 29, 2009·Clinical Chemistry and Laboratory Medicine : CCLM·Giuseppe LippiEmmanuel J Favaloro
May 6, 2010·Clinical Chemistry and Laboratory Medicine : CCLM·Emmanuel J FavaloroNaomi Hocker
Mar 14, 2013·Seminars in Thrombosis and Hemostasis·Emmanuel J FavaloroGiuseppe Lippi
Feb 16, 2015·Seminars in Thrombosis and Hemostasis·Brandon J McMahon, Hau C Kwaan
Feb 24, 2015·Seminars in Thrombosis and Hemostasis·Nicoletta Riva, Walter Ageno

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Citations

Nov 3, 2017·Clinical Chemistry and Laboratory Medicine : CCLM·Mario Plebani
Sep 27, 2020·International Journal of Laboratory Hematology·Akbar DorgalalehFariba Rad
May 4, 2018·Clinical Chemistry and Laboratory Medicine : CCLM·Emmanuel J FavaloroGiuseppe Lippi
Nov 21, 2020·Haemophilia : the Official Journal of the World Federation of Hemophilia·Emmanuel J FavaloroJennifer Curnow
Jun 25, 2021·World Journal of Transplantation·Ramesh KumarRajeev Nayan Priyadarshi

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