Subscribe to RSS
Please copy the URL and add it into your RSS Feed Reader.
https://www.thieme-connect.de/rss/thieme/en/10.1055-s-00035024.xml
Download PDF
Thromb Haemost 1999; 81(01): 66-70
DOI: 10.1055/s-0037-1614420
DOI: 10.1055/s-0037-1614420
Review Article
Influence of Three Types of Automated Coagulometers on the International Sensitivity Index (ISI) of Rabbit, Human, and Recombinant Human Tissue Factor Preparations
A Multicenter StudyFurther 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)
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.
MissingLinkText
MissingLinkText
-
References
- 1 WHO Expert Committee on Biological Standardization. Thirtythird Report. WHO Tech Rep Ser 1983; 687: 81-105.
- 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.
- 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.
- 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.
- 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.
- 6 Van den Besselaar. Multi-center study of replacement of the international reference preparation for thromboplastin, rabbit, plain. Thromb Haemost 1993; 70: 794-9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 15 Brien WF, Crawford L, Wood DE. Discrepant Results in INR testing. Thromb Haemost 1994; 72: 986-7.
- 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.
- 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.
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.
- 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.
- 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.
- 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.
- 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.
- 6 Van den Besselaar. Multi-center study of replacement of the international reference preparation for thromboplastin, rabbit, plain. Thromb Haemost 1993; 70: 794-9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 15 Brien WF, Crawford L, Wood DE. Discrepant Results in INR testing. Thromb Haemost 1994; 72: 986-7.
- 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.
- 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.