Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination

A. M H P van den Besselaar, T. W. Barrowcliffe, L. L. Houbouyan-Réveillard, J. Jespersen, M. Johnston, L. Poller, A. Tripodi

Research output: Contribution to journalArticle

Abstract

Reliable international normalized ratio (INR) determinatlon depends on accurate values for international sensitivity index (ISI) and mean normal prothrombin time (MNPT). Local ISI calibration can be performed to obtain reliable INR. Alternatively, the laboratory may determine INR directly from a line relating local log(prothrombin time [PT]) to log(INR). This can be done by means of lyophilized or frozen plasmas to which certified values of PT or INR have been assigned. Currently there is one procedure for local calibration with certified plasmas which is a modification of the WHO method of ISI determination. In the other procedure, named 'direct' INR determination, certified plasmas are used to calculate a line relating log(PT) to log(INR). The number of certified plasmas for each procedure depends on the method of preparation and type of plasma. Lyophilization of plasma may induce variable effects on the INR, the magnitude of which depends on the type of thromboplastin used. Consequently, the manufacturer or supplier of certified plasmas must assign the values for different (reference) thromboplastins and validate the procedure for reliable ISI calibration or 'direct' INR determination. Certification of plasmas should be performed by at least three laboratories. Multiple values should be assigned if the differences between thromboplastin systems are greater than 10%. Testing of certified plasmas for ISI calibration may be performed in quadruplicate in the same working session. It is recommended to repeat the measurements on three sessions or days to control day-to-day variation. Testing of certified plasmas for 'direct' INR determination should be performed in at least three sessions or days. Correlation lines for ISI calibration and for 'direct' INR determination should be calculated by means of orthogonal regression. Quality assessment of the INR with certified plasmas should be performed regularly and should be repeated whenever there is a change in reagent batch or in instrument. Discrepant results obtained by users of certified plasmas should be reported to manufacturers or suppliers.

Original languageEnglish
Pages (from-to)1946-1953
Number of pages8
JournalJournal of Thrombosis and Haemostasis
Volume2
Issue number11
DOIs
Publication statusPublished - Nov 2004

Fingerprint

International Normalized Ratio
Certification
Calibration
Guidelines
Prothrombin Time
Thromboplastin
Freeze Drying
Reference Values

Keywords

  • Anticoagulant control
  • International normalized ratio
  • International sensitivity index
  • Prothrombin time
  • Thromboplastin

ASJC Scopus subject areas

  • Medicine(all)

Cite this

van den Besselaar, A. M. H. P., Barrowcliffe, T. W., Houbouyan-Réveillard, L. L., Jespersen, J., Johnston, M., Poller, L., & Tripodi, A. (2004). Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination. Journal of Thrombosis and Haemostasis, 2(11), 1946-1953. https://doi.org/10.1111/j.1538-7836.2004.00970.x

Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination. / van den Besselaar, A. M H P; Barrowcliffe, T. W.; Houbouyan-Réveillard, L. L.; Jespersen, J.; Johnston, M.; Poller, L.; Tripodi, A.

In: Journal of Thrombosis and Haemostasis, Vol. 2, No. 11, 11.2004, p. 1946-1953.

Research output: Contribution to journalArticle

van den Besselaar, AMHP, Barrowcliffe, TW, Houbouyan-Réveillard, LL, Jespersen, J, Johnston, M, Poller, L & Tripodi, A 2004, 'Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination', Journal of Thrombosis and Haemostasis, vol. 2, no. 11, pp. 1946-1953. https://doi.org/10.1111/j.1538-7836.2004.00970.x
van den Besselaar AMHP, Barrowcliffe TW, Houbouyan-Réveillard LL, Jespersen J, Johnston M, Poller L et al. Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination. Journal of Thrombosis and Haemostasis. 2004 Nov;2(11):1946-1953. https://doi.org/10.1111/j.1538-7836.2004.00970.x
van den Besselaar, A. M H P ; Barrowcliffe, T. W. ; Houbouyan-Réveillard, L. L. ; Jespersen, J. ; Johnston, M. ; Poller, L. ; Tripodi, A. / Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination. In: Journal of Thrombosis and Haemostasis. 2004 ; Vol. 2, No. 11. pp. 1946-1953.
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abstract = "Reliable international normalized ratio (INR) determinatlon depends on accurate values for international sensitivity index (ISI) and mean normal prothrombin time (MNPT). Local ISI calibration can be performed to obtain reliable INR. Alternatively, the laboratory may determine INR directly from a line relating local log(prothrombin time [PT]) to log(INR). This can be done by means of lyophilized or frozen plasmas to which certified values of PT or INR have been assigned. Currently there is one procedure for local calibration with certified plasmas which is a modification of the WHO method of ISI determination. In the other procedure, named 'direct' INR determination, certified plasmas are used to calculate a line relating log(PT) to log(INR). The number of certified plasmas for each procedure depends on the method of preparation and type of plasma. Lyophilization of plasma may induce variable effects on the INR, the magnitude of which depends on the type of thromboplastin used. Consequently, the manufacturer or supplier of certified plasmas must assign the values for different (reference) thromboplastins and validate the procedure for reliable ISI calibration or 'direct' INR determination. Certification of plasmas should be performed by at least three laboratories. Multiple values should be assigned if the differences between thromboplastin systems are greater than 10{\%}. Testing of certified plasmas for ISI calibration may be performed in quadruplicate in the same working session. It is recommended to repeat the measurements on three sessions or days to control day-to-day variation. Testing of certified plasmas for 'direct' INR determination should be performed in at least three sessions or days. Correlation lines for ISI calibration and for 'direct' INR determination should be calculated by means of orthogonal regression. Quality assessment of the INR with certified plasmas should be performed regularly and should be repeated whenever there is a change in reagent batch or in instrument. Discrepant results obtained by users of certified plasmas should be reported to manufacturers or suppliers.",
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