Low interinstrument variability of the international normalized ratio with the coagamate X2/Simplastin excel system.

Abstract

Minimizing the interlaboratory variability of the International Normalized Ratio (INR) for patients receiving coumarin therapy will require local laboratory calibration of individual coagulation instrument/reagent systems. However, some laboratories possess multiple coagulation instruments of the same model, and it is unclear if each instrument would require separate calibration. To address this question, a controlled study was performed that examined the interinstrument variability of the INR on three separate Coagamate X2 coagulometers (Organon Teknika, Durham, NC) using the Simplastin Excel reagent (Organon Teknika) (International Sensitivity Index = 2.14). The interinstrument coefficient of variation (CV) of the INR among the three instruments was 3.4% and 3.5% for patient control plasmas (n = 20) and coumarin plasmas (n = 40, INR range 1.5-4.6), respectively. The number of discordant INRs between paired instruments (one INR within and one INR out of the therapeutic range, plus a difference of at lest 0.4 INR units) was very low (0%). The interinstrument INR CVs for three commercial quality control plasmas were 2.6% (INR = 0.92), 4.1% (INR = 2.1), and 6.3% (INR = 4.5), and correlated well with the low CVs for patient samples. This study showed that the Coagamate X2/Simplastin Excel system is capable of very low interinstrument INR variability, and surpasses the interlaboratory CVs reported in the literature. Formal calibration of a single instrument may be adequate for laboratories possessing multiple instruments of the same model.