Time to think outside the box? Prothrombin time, international normalised ratio, international sensitivity index, mean normal prothrombin time and measurement of uncertainty: a novel approach to standardisation

Pathology
Emmanuel J FavaloroVioleta Ule

Abstract

The prothrombin time (PT) assay is the most clinically ordered coagulation test, and most often used for monitoring of vitamin K antagonist therapy (e.g., warfarin), where results are expressed as an international normalised ratio (INR). The INR is in essence the patient's PT 'mathematically adjusted' to a standardised value taking into account the peculiarities of the test system as defined by an ISI (international sensitivity index) and MNPT (mean normal prothrombin time). Although some manufacturers provide assigned ISI values for specific PT reagents and instrumentation, it is still recommended practice that laboratories check or validate these ISIs, as well as estimate the MNPT. Where an ISI is not provided by a manufacturer, the laboratory needs to estimate its own value. Current recommendations suggest the use of commercial reference-plasma calibration sets, but there is limited information on the performance of these in the field. We report a comparative study that assessed the utility of three such commercial calibration plasma sets, used as recommended, as well as alternate or supplementary procedures for estimation of ISI and MNPT. The latter included one novel approach using comparative data of 'existing' versus 're...Continue Reading

References

Jun 3, 1998·British Journal of Haematology
Nov 21, 2000·Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis·D M Adcock, S Duff
Feb 12, 2005·Seminars in Thrombosis and Hemostasis·Alexander S Gallus

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Citations

Dec 18, 2009·Clinical Chemistry and Laboratory Medicine : CCLM·Emmanuel J Favaloro, Giuseppe Lippi
May 6, 2010·Clinical Chemistry and Laboratory Medicine : CCLM·Emmanuel J FavaloroNaomi Hocker
Mar 27, 2010·Biologicals : Journal of the International Association of Biological Standardization·A M H P van den BesselaarA Tripodi
Aug 12, 2009·Clinics in Laboratory Medicine·Valerie L Ng
Mar 13, 2014·American Journal of Clinical Pathology·Hwa Jeen LeeHyun Kyung Kim
Apr 3, 2020·Clinical Chemistry and Laboratory Medicine : CCLM·Yong Kwan LimHye Ryoun Kim
Sep 27, 2020·International Journal of Laboratory Hematology·Akbar DorgalalehFariba Rad

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