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Thromb Haemost 1999; 81(01): 66-70
DOI: 10.1055/s-0037-1614420
Review Article
Schattauer GmbH

Influence of Three Types of Automated Coagulometers on the International Sensitivity Index (ISI) of Rabbit, Human, and Recombinant Human Tissue Factor Preparations

A Multicenter Study
A. M. H. P. van den Besselaar
1   From the Haemostasis and Thrombosis Research Center, Leiden University Medical Center, Leiden, The Netherlands
,
L. L. Houbouyan
2   Hôpital Ambroise Paré, Service Central d'immuno-hématologie, Boulogne, France
,
M. F. Aillaud
3   Hôpital de la Timone, Laboratoire d'hématologie, Marseille, France
,
K. W. E. Denson
4   Thame Thrombosis and Haemostasis Research Foundation, Thame, Oxon, UK
,
M. Johnston
5   Hamilton Civic Hospitals Research Centre, Hamilton, Ontario, Canada
,
S. Kitchen
6   Royal Hallamshore Hospital, Department of Haematology, Sheffield, UK
,
T. L. Lindahl
7   University Hospital, Department of Clinical Chemistry, Linköping, Sweden
,
M. Marren
8   Beaumont Hospital, Coagulation Laboratory, Department of Haematology, Dublin, Ireland
,
M. E. Martinuzzo
9   University Institute of Biomedical Sciences, Favaloro Foundation, Buenos Aires, Argentina
,
C. Droullé
10   Hôpital Robert Debré, Laboratoire Central d'hématologie, Reims, France
,
A. Tripodi
11   A. Bianchi Bonomi Hemophilia and Thrombosis Centre, IRCCS Maggiore Hospital, Milano, Italy
,
C. Vergnes
12   Hôpital Cardiologique Haut Lévêque, Laboratoire d'hémobiologie, Pessac, France
› Author Affiliations
Further Information

Correspondence to:

Dr. A. M. H. P. van den Besselaar
Haemostasis and Thrombosis
Research Centre, Building 1
C2-R, Leiden University Medical Centre
P.O. Box 9600, 2300 RC Leiden
The Netherlands
Phone: +31 71 526 1894   
Fax: +31 71 526 6755

Publication History

Received27 February 1998

Accepted after resubmission23 September 1998

Publication Date:
08 December 2017 (online)

 
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Summary

Five tissue factor reagents and three types of automated instruments for prothrombin time (PT) determination were studied in an international multicenter collaborative exercise. The purpose of this work was to determine the international sensitivity index (ISI) for each combination of reagent and instrument against the international reference preparation RBT/90. Each type of instrument was used by 3 or 4 centers to assess the interlaboratory variation of the ISI. The interlaboratory variation of the ISI for each combination of reagent and instrument ranged between 0.4% and 7.8% coefficient of variation. For three reagents, the mean ISI values for ACL (nephelometric) and STA (mechanical) were practically identical, but the mean ISI values for MLA (photo-optical) were at least 10% higher. For two other reagents prepared from rabbit tissue, the mean ISI values increased in the order ACL, STA, MLA. The widest range of mean ISI values was noted with one rabbit tissue factor reagent: 1.68 for ACL and 2.00 for MLA. Exclusion of patient specimens with INR <1.5 and INR >4.5 determined by the international reference preparation resulted in a slight decrease of the mean ISI.

The interlaboratory variation of the International Normalized Ratio (INR) was assessed from the results obtained with common lyophilized and deep-frozen plasmas. The use of instrument-specific ISI values resulted in reduced interlaboratory variation of the INR. It is recommended that thromboplastin manufacturers provide instrument-specific ISI values.


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  • References

  • 1 WHO Expert Committee on Biological Standardization. Thirtythird Report. WHO Tech Rep Ser 1983; 687: 81-105.
    PubMedGoogle Scholar
  • 2 Poggio M, Van den Besselaar AMHP, Van der Velde EA, Bertina RM. The effect of some instruments for prothrombin time testing on the International Sensitivity Index (ISI) of two rabbit tissue thromboplastin reagents. Thromb Haemost 1989; 62: 868-74.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 3 Ray MJ, Smith IR. The dependence of the International Sensitivity Index on the coagulometer used to perform the prothrombin time. Thromb Haemost 1990; 63: 424-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 4 Clarke K, Taberner DA, Thomson JM, Morris JA, Poller L. Assessment of value of calibrated lyophilized plasmas to determine International Sensitivity Index for coagulometers. J Clin Pathol 1992; 45: 58-60.
    CrossrefPubMedGoogle Scholar
  • 5 Poller L, Triplett DA, Hirsh J, Carroll J, Clarke K. The value of plasma calibrants in correcting coagulometer effects on International Normalized Ratios. Am J Clin Pathol 1995; 103: 358-65.
    CrossrefPubMedGoogle Scholar
  • 6 Van den Besselaar. Multi-center study of replacement of the international reference preparation for thromboplastin, rabbit, plain. Thromb Haemost 1993; 70: 794-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 7 Poller L, Houghton D, Outschoorn AS. Statistical analysis of results of a collaborative study of a human recombinant tissue thromboplastin preparation to serve as a USP reference standard (collaborative assay by comparative clotting times). Pharmacopeial Forum 1996; 22: 2946-55.
    PubMedGoogle Scholar
  • 8 Van der Velde EA. Orthogonal regression equation. In: Thromboplastin Calibration and Oral Anticoagulant Control. Van den Besselaar AMHP, Gralnick HR, Lewis SM. eds Boston: Martinus Nijhoff Publishers; 1984: 25-39.
    Google Scholar
  • 9 Duncan EM, Casey CR, Duncan BM, Lloyd JV. Effect of concentration of trisodium citrate anticoagulant on calculation of the International Normalized Ratio and the International Sensitivity Index of Thromboplastin. Thromb Haemost 1994; 72: 84-8.
    PubMedGoogle Scholar
  • 10 Chantarangkul V, Tripodi A, Clerici M, Negri B, Mannucci PM. Assessment of the influence of citrate concentration on the international normal-ized ratio (INR) determined with twelve reagent-instrument combinations. Thromb Haemost 1998; 80: 258-62.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 11 Tripodi A, Poller L, Van den Besselaar AMHP, Mannucci PM. A proposed scheme for calibration of international reference preparations of thromboplastin for the prothrombin time. Thromb Haemost 1995; 74: 1368-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 12 Tripodi A, Chantarangkul V, Negri B, Clerici M, Mannucci PM. International Collaborative Study for the Calibration of a Proposed Reference Preparation for Thromboplastin, Human Recombinant, Plain. Thromb Haemost 1998; 79: 439-43.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 13 Tomenson JA. A statistician's independent evaluation. In: Thromboplastin Calibration and Oral Anticoagulant Control. Van den Besselaar AMHP, Gralnick HR, Lewis SM. eds Boston: Martinus Nijhoff Publishers; 1984: 87-108.
    Google Scholar
  • 14 Van den Besselaar AMHP, Van der Velde EA. The manufacturers' study. In: Thromboplastin Calibration and Oral Anticoagulant Control. Van den Besselaar AMHP, Gralnick HR, Lewis SM. eds Boston: Martinus Nijhoff Publishers; 1984: 127-49.
    Google Scholar
  • 15 Brien WF, Crawford L, Wood DE. Discrepant Results in INR testing. Thromb Haemost 1994; 72: 986-7.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 16 Kitchen S, Jennings I, Woods TAL, Walker ID, Preston FE. Two recombinant tissue factor reagents compared to conventional thromboplastins for determination of International Normalised Ratio: a thirty-three-laboratory collaborative study. Thromb Haemost 1996; 76: 372-6.
    PubMedGoogle Scholar
  • 17 Houbouyan LL, Goguel AF. Long-term French experience in INR standardization by a procedure using plasma calibrants. Am J Clin Pathol 1997; 108: 83-9.
    CrossrefPubMedGoogle Scholar

Correspondence to:

Dr. A. M. H. P. van den Besselaar
Haemostasis and Thrombosis
Research Centre, Building 1
C2-R, Leiden University Medical Centre
P.O. Box 9600, 2300 RC Leiden
The Netherlands
Phone: +31 71 526 1894   
Fax: +31 71 526 6755

  • References

  • 1 WHO Expert Committee on Biological Standardization. Thirtythird Report. WHO Tech Rep Ser 1983; 687: 81-105.
    PubMedGoogle Scholar
  • 2 Poggio M, Van den Besselaar AMHP, Van der Velde EA, Bertina RM. The effect of some instruments for prothrombin time testing on the International Sensitivity Index (ISI) of two rabbit tissue thromboplastin reagents. Thromb Haemost 1989; 62: 868-74.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 3 Ray MJ, Smith IR. The dependence of the International Sensitivity Index on the coagulometer used to perform the prothrombin time. Thromb Haemost 1990; 63: 424-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 4 Clarke K, Taberner DA, Thomson JM, Morris JA, Poller L. Assessment of value of calibrated lyophilized plasmas to determine International Sensitivity Index for coagulometers. J Clin Pathol 1992; 45: 58-60.
    CrossrefPubMedGoogle Scholar
  • 5 Poller L, Triplett DA, Hirsh J, Carroll J, Clarke K. The value of plasma calibrants in correcting coagulometer effects on International Normalized Ratios. Am J Clin Pathol 1995; 103: 358-65.
    CrossrefPubMedGoogle Scholar
  • 6 Van den Besselaar. Multi-center study of replacement of the international reference preparation for thromboplastin, rabbit, plain. Thromb Haemost 1993; 70: 794-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 7 Poller L, Houghton D, Outschoorn AS. Statistical analysis of results of a collaborative study of a human recombinant tissue thromboplastin preparation to serve as a USP reference standard (collaborative assay by comparative clotting times). Pharmacopeial Forum 1996; 22: 2946-55.
    PubMedGoogle Scholar
  • 8 Van der Velde EA. Orthogonal regression equation. In: Thromboplastin Calibration and Oral Anticoagulant Control. Van den Besselaar AMHP, Gralnick HR, Lewis SM. eds Boston: Martinus Nijhoff Publishers; 1984: 25-39.
    Google Scholar
  • 9 Duncan EM, Casey CR, Duncan BM, Lloyd JV. Effect of concentration of trisodium citrate anticoagulant on calculation of the International Normalized Ratio and the International Sensitivity Index of Thromboplastin. Thromb Haemost 1994; 72: 84-8.
    PubMedGoogle Scholar
  • 10 Chantarangkul V, Tripodi A, Clerici M, Negri B, Mannucci PM. Assessment of the influence of citrate concentration on the international normal-ized ratio (INR) determined with twelve reagent-instrument combinations. Thromb Haemost 1998; 80: 258-62.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 11 Tripodi A, Poller L, Van den Besselaar AMHP, Mannucci PM. A proposed scheme for calibration of international reference preparations of thromboplastin for the prothrombin time. Thromb Haemost 1995; 74: 1368-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 12 Tripodi A, Chantarangkul V, Negri B, Clerici M, Mannucci PM. International Collaborative Study for the Calibration of a Proposed Reference Preparation for Thromboplastin, Human Recombinant, Plain. Thromb Haemost 1998; 79: 439-43.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 13 Tomenson JA. A statistician's independent evaluation. In: Thromboplastin Calibration and Oral Anticoagulant Control. Van den Besselaar AMHP, Gralnick HR, Lewis SM. eds Boston: Martinus Nijhoff Publishers; 1984: 87-108.
    Google Scholar
  • 14 Van den Besselaar AMHP, Van der Velde EA. The manufacturers' study. In: Thromboplastin Calibration and Oral Anticoagulant Control. Van den Besselaar AMHP, Gralnick HR, Lewis SM. eds Boston: Martinus Nijhoff Publishers; 1984: 127-49.
    Google Scholar
  • 15 Brien WF, Crawford L, Wood DE. Discrepant Results in INR testing. Thromb Haemost 1994; 72: 986-7.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 16 Kitchen S, Jennings I, Woods TAL, Walker ID, Preston FE. Two recombinant tissue factor reagents compared to conventional thromboplastins for determination of International Normalised Ratio: a thirty-three-laboratory collaborative study. Thromb Haemost 1996; 76: 372-6.
    PubMedGoogle Scholar
  • 17 Houbouyan LL, Goguel AF. Long-term French experience in INR standardization by a procedure using plasma calibrants. Am J Clin Pathol 1997; 108: 83-9.
    CrossrefPubMedGoogle Scholar

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