Document Detail

Multi-center study of replacement of the international reference preparation for thromboplastin, rabbit, plain.
MedLine Citation:
PMID:  8128437     Owner:  NLM     Status:  MEDLINE    
A multi-center study of the three W.H.O. international reference preparations (IRP) for thromboplastin has been performed. The main purpose of the study was the determination of the mean international sensitivity index (ISI) of a proposed replacement IRP for thromboplastin, rabbit, plain. Twenty laboratories in Europe, North America, and Australasia participated in the study. All clotting times were determined with the manual technique. The inter-laboratory variation of the ISI was considered as the relevant parameter for assessment of ISI precision. Low interlaboratory variation was observed in the calibration of rabbit thromboplastin against rabbit thromboplastin (2.9-3.0% coefficient of variation of calibration line slope). Relatively high interlaboratory variation was observed in the calibration of rabbit against human thromboplastin (3.7-7.2 CV). Intermediary interlaboratory variation was obtained in the comparison of rabbit or human plain thromboplastin with bovine combined thromboplastin (3.5-4.0% CV). These findings confirm the principle of like-to-like calibration in biological standardization. The mean ISI values based on the IRP for rabbit thromboplastin (RBT/79) are in excellent agreement with those obtained with the IRP for bovine thromboplastin (OBT/79). In contrast, the mean ISI values determined with the IRP for human thromboplastin (BCT/253) were 6% lower than those with RBT/79. This bias may be caused by a difference in design of the two historical calibration studies. The mean ISI of the proposed replacement IRP for thromboplastin, rabbit, plain obtained by calibration against RBT/79 was 1.035 (standard error: 0.027). It is recommended to round the mean ISI off to 1.0. Opportunity was also taken to compare a lyophilized normal pooled plasma with fresh individual normal plasmas.(ABSTRACT TRUNCATED AT 250 WORDS)
A M van den Besselaar
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Thrombosis and haemostasis     Volume:  70     ISSN:  0340-6245     ISO Abbreviation:  Thromb. Haemost.     Publication Date:  1993 Nov 
Date Detail:
Created Date:  1994-04-11     Completed Date:  1994-04-11     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7608063     Medline TA:  Thromb Haemost     Country:  GERMANY    
Other Details:
Languages:  eng     Pagination:  794-9     Citation Subset:  IM    
Department of Haematology, Leiden University Hospital, The Netherlands.
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MeSH Terms
Blood Preservation
Freeze Drying
Prothrombin Time*
Rabbits / blood*
Reference Standards
Thromboplastin / standards*
World Health Organization
Reg. No./Substance:

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