WHO/BS/2016.2294 Calibration of the Proposed 5th IS for Thromboplastin, human, recombinant, plain (rTF/16; study code 14/001) and the Proposed 5th IS for Thromboplastin, rabbit, plain (RBT/16; study code 15/001)

Overview

Stocks of the current 4th International Standard for Thromboplastin, human, recombinant, plain (coded rTF/09) and the current 4th International Standard for Thromboplastin, rabbit, plain (coded RBT/05) are running low. Candidate replacement materials have been prepared (provisionally coded 14/001 and 15/001, respectively). This report describes the calibration of the proposed 5 th International Standard for Thromboplastin, human, recombinant, plain, and the proposed 5th International Standard for Thromboplastin, rabbit, plain.

An international collaborative study was carried out for the assignment of International Sensitivity Index (ISI) to the candidate materials. Results were obtained from 20 laboratories. The validity of each and every ISI assessment was checked using criteria published by the WHO Expert Committee on Biological Standardization. Only valid ISI assessments were used to calculate the mean ISI for each candidate.