Original scientific paper

Evaluation of the Steelex M600H coagulometer prothrombin time-international normalized ratio assay with Steelex test reagents

Yasemin U. Budak ; Department of Clinical Laboratory, Sevket Yilmaz Education and Training Hospital, Bursa, Turkey
Kağan Huysal ; Department of Clinical Laboratory, Yuksek Ihtisas Education and Training Hospital, Bursa, Turkey
Murat Polat ; Department of General Surgery, Sevket Yilmaz Education and Training Hospital, Bursa, Turkey
Gülsevil Tarakçi ; Department of Clinical Laboratory, Sevket Yilmaz Education and Training Hospital, Bursa, Turkey
Hakan Uçar ; Department of Cardiology, Sevket Yilmaz Education and Training Hospital, Bursa, Turkey

Abstract

Introduction: The aim of the present study was to validate prothrombin time (PT) international nor-malized ratio (INR) results obtained using Steelex test reagents and a Steelex coagulometer (Steelex Scientific Instrument Company, Beijing, China), in comparison with use of a well-established standard test employing Pacific Hemostasis reagents (Fisher Diagnostics, Middletown, VA, USA) and Teco Coatron A4 coagulometer (Teco Medical Instruments GmbH, Neufahrn, Germany).
Materials and methods: Between- and within-day coefficients of variation (CVs) of both assays were calculated using control samples provided by the test manufacturers. Samples from 90 subjects were collected and INR values were determined in a double-blind parallel manner employing both systems.
Results: The within-day coefficients of variation (CVs) in INR estimates ranged from 2.6% (INR = 1.12) to 3.1% (INR = 2.51) for the Steelex system and from 2.1% (INR = 1.09) to 1.8% (INR = 2.8) for the Pacific test; the between-day values ran from 3.4% (INR = 1.16) to 7.9% (INR = 2.64) and from 3.3% (INR = 1.1) to 2.3% (INR = 2.7), respectively. Passing-Bablok fit of the of the Steelex and Pacific methods yielded the equation: Steelex INR = 0.85 (0.79-0.91) × Pacific INR + 0.12 (-0.02-0.21), whereas the CUSUM linearity P value was <0.01. The mean bias as determined by the Bland-Altman test was -0.156 (-0.912-0.600).
Conclusion: The results obtained using Steelex reagents and the M600H coagulometer are not equivalent to those obtained using Pacific Hemostasis reagents and a Teco Coatron A4 coagulome-ter, at least in the therapeutic range.

Keywords

Steelex coagulometer; prothrombin time, INR, evaluation

Hrčak ID:

77407

URI

https://hrcak.srce.hr/77407

Publication date:

15.2.2012.

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