Evaluation of International Normalized Ratios by a Controlled Field Survey with 4 Different Thromboplastin Reagents

Mutsuyoshi Kazama; Setsuko Suzuki; Takeshi Abe; Chieko Tahara; Chisato Shimazu; Yoshiko Akiyama; Katsumi Higashi; Izumi Ishiguro; Toshiyuki Kimura; Shigemi Motoi; Kazuo Tsukai; Masaki Kobayashi; Yoshimasa Niwa; Hisao Makita; Yoko Yasumuro; Toshihiko Nakatake

doi:10.1055/s-0038-1647353

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1990; 64(04): 535-541
DOI: 10.1055/s-0038-1647353

Original Article

Schattauer GmbH Stuttgart

Evaluation of International Normalized Ratios by a Controlled Field Survey with 4 Different Thromboplastin Reagents

Mutsuyoshi Kazama

¹The Department of Medicine and Central Clinical Laboratory, Teikyo University School of Medicine, Tokyo, Japan

,

Setsuko Suzuki

²Central Clinical Laboratory, Yokosuka Kyosai Hospital, Yokosuka, Japan

,

Takeshi Abe

¹The Department of Medicine and Central Clinical Laboratory, Teikyo University School of Medicine, Tokyo, Japan

,

Chieko Tahara

¹The Department of Medicine and Central Clinical Laboratory, Teikyo University School of Medicine, Tokyo, Japan

,

Chisato Shimazu

¹The Department of Medicine and Central Clinical Laboratory, Teikyo University School of Medicine, Tokyo, Japan

,

Yoshiko Akiyama

³Central Clinical Laboratory, Tokyo University Faculty of Medicine, Tokyo, Japan

,

Katsumi Higashi

⁴Central Clinical Laboratory, Kyorin University School of Medicine, Tokyo, Japan

,

Izumi Ishiguro

⁵Central Clinical Laboratory, Kanto Rosai Hospital, Tokyo

,

Toshiyuki Kimura

⁶Central Clinical Laboratory, Sapporo Medical College, Sapporo, Japan

,

Shigemi Motoi

⁷Central Clinical Laboratory, Osaka University School of Medicine, Osaka, Japan

,

Kazuo Tsukai

⁸Central Clinical Laboratory, Tokushima Prefectural Central Hospital, Tokyshima, Japan

,

Masaki Kobayashi

⁹Life Information Analysis Center, Tokyo, Japan

,

Yoshimasa Niwa

¹⁰Central Clinical Laboratory, Nara Medical College, Nara

,

Hisao Makita

¹¹Central Clinical Laboratory, Hiratsuka Kyousai Hospital, Kanagawa, Japan

,

Yoko Yasumuro

¹²Central Clinical Laboratory, St. Marianna University School of Medicine, Kanagawa, Japan

,

Toshihiko Nakatake

¹³School of Health Science, Kyorin University, Tokyo, Japan

› Author Affiliations

Abstract

PDF Download

Summary

A nationwide survey has been performed in Japan involving 75 laboratories to assess the relative reliability of different methods of reporting prothrombin time results in anticoagulant control. The interchangeability of results using prothrombin time, prothrombin activity percentage, prothrombin ratio and international normalized ratios (INR) were compared with four different thromboplastin reagents and a range of coagulometers. A secondary batch of reference thromboplastin of human brain origin (BCT/454) was used to calibrate the local thromboplastins and for comparison of methods of reporting. The study revealed the closest agreement of the results between BCT and the other reagents, and the regression lines of these reagents were almost identical, when the results were reported as INR. Box-Whisker plot analysis showed that the distribution of the results was large with the more deficient plasmas with all methods of reporting. It was found by this analysis that the interchangeability of the results was greatest when the results were expressed by INR, because the mean values obtained of each plasma using different thromboplastin reagents gave the lowest CV and the frequency of the far-out data was least, compared with the other methods of expression. On the other hand, the type of coagulometer had almost as much effect as the thromboplastin reagent on the prothrombin time, even if INR was used. Interchangeability of INR would be further improved by providing ISI values for each reagent/ instrument combination.

PDF (509 kb)

References

References
1 WHO Expert Committee on Biological Standardization. 33 Report WHO Tech Rep Ser 1983 687. 81-105
2 Loeliger EA, Poller L, Samama M, Thomson JM, van den Besselaar AM, Vermylen J, Verstraete M. Questions and answers on prothrombin time standardization in oral anticoagulant control. Thromb Haemostas 1985; 54: 515-517
3 Beck EA. How can we improve long-term anticoagulation. Schweiz Med Wochenschr 1985; 115: 1495-500
4 Lechner K, Kroninger C, Kyrle P, Geissler K, Niessner H, Pabinger I, Panzer S, Gossinger H, Betterheim P, Hinterberger W. Oral anticoagulant therapy - Renaissance of an old therapy. Wien Klin Wochenschr 1987; 99: 203-210
5 Poller L. INR-calibration of the therapeutic range. Adv Exp Med Biol 1987; 214: 95-112
6 Hull R, Hirsh J, Jay R, Carter C, England C, Gent RN M, Trupie AG G, McLoughlin D, Didd P, Thomas M, Raskab G, Ockelford P. Different intensities of oral anticoagulant therapy in the treatment of proximal-vein thrombosis. N Engl J Med 1982; 307: 1676-1681
7 Hermans J, van den Besselaar AM P H, Loeliger EA, van den Velde EA. A collaborative calibration study of reference materials for thromboplastins. Thromb Haemostas (Stuttgart) 1983; 50: 712-717
8 Poller L, Taberner DA. Dosage and control of oral anticoagulants: An international Survey. Br J Haematol 1982; 51: 479-485
9 Poller L. Laboratory control of anticoagulant therapy. Sem Thromb Hemostas 1986; 12 (01) 13-19
10 Tukey JW. Exploratory Data Analysis. Addison-Wesley, Reading, MA 1977; 339
11 Thomson JM, Tomenson JA, Poller L. The calibration of the second primary international reference preparation for thromboplastin (thromboplastin, human, plain, coded BCT/253). Thromb Haemostas 1984; 52: 336-343
12 Hirsh J. Effectiveness of anticoagulation. Sem Thromb Hemostas 1986; 12: 1-35
13 Loeliger EA, van den Besselaar AM H P, Lewis SM. Reliability and clinical impact of the normalization of the prothrombin times in oral anticoagulant control. Thromb Haemostas 1985; 53: 148-154
14 Lammle B, Furlan M, Sulzer I. Comparison of a sensitive rabbit brain thromboplastin and a human placenta thromboplastin for thromboplastin time determination. Schweiz Med Wochenschr 1989; 119: 178-83
15 Taberner DA, Poller L, Thomson JM, Darvy KV. Effect of international sensitivity index (ISI) of thromboplastin on precision of international normalized ratios (INR). J Clin Pathol 1989; 42: 92-96
16 Palareti G, Coccheri S, Poggi M, Bonetti M, Cervi V, Mazzuca A, Savoia M, Veri L, Fiori F, Gaspari G. et al. Oral anticoagulant therapy control: Evidence that INR expression improves the inter-laboratory comparability of results - the Bologna oral anticoagulant control exercise. Thromb Haemostas 1987; 58: 905-910
17 Evatt BL, Brogan D, Triplett DA, Waters G. Effect of thromboplastin and instrumentation on the prothrombin time test. Clin Lab Haematol 1981; 3: 331-342
18 Triplett DA, Evatt BL, van den Besselaar AM H P. Proficiency testing and standardization of prothrombin time: Potential use of thromboplastin calibration in the United States. In: Thromboplastin Calibration and Oral Anticoagulant Control van den Besselaar AM H P, Gralnick HR, Lewis SM. (eds). Martinus Nijhoff Publishers; Boston, MA: 1984: 209-218
19 van den Besselaar AM. Standardization of the prothrombin time in oral anticoagulant control. Haemostasis 1985; 15: 271-277
20 Poller L, Hirsh J. Special report: a simple system for the derivation of international normalized ratios for the report of prothrombin time results with North American Thromboplastin reagents. Am J Clin Pathol 1989; 92: 124-126
21 Poller L. A simple nomogram for the derivation of international normalized ratios for the standardization of prothrombin times. Thromb Haemostas 1988; 60: 18-20