title: A collaborative study to establish the 1st national standard of prekallikrein activator in Korea.
abstract: The aim of this study was to establish the first national standard for prekallikrein activator (PKA) calibrating to the first international standard PKA. A collaborative study among five laboratories, including three manufacturers and two national control laboratories, was carried out to evaluate the suitability of a candidate to serve as a national standard of PKA. The candidate was manufactured in GMP facility following approved human serum albumin fractionation procedure and freeze-dried 5% albumin solution containing PKA. Participants were provided with sufficient samples and asked to use lab-made prekallikrein substrate prepared in accordance with European Pharmacopeia and also to use a commercial prekallikrein provided as part of the study. The PKA concentration of the candidate was 61.8 IU per vial using lab-made prekallikrein. However, the concentration was 54.2 IU per vial using commercial prekallikrein. The variability obtained at each laboratory ranged from 1.9% to 5.1% for within-a-day and from 5.6% to 9.0% for day-to-day. The candidate showed excellent stability from accelerated degradation study and real-time stability study. As a conclusion, the candidate preparation was suitable to serve as a Korean National Standard for PKA.
authors: National Center for Lot Release, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Ohsong Bio Complex 643 Yeonje-ri, Kangwei-myeon, Chungwon-kun, Chungbuk-do 363-951, Republic of Korea. kshin33@korea.kr
authors: In Soo
authors: IS
authors: Shin
authors: Choong Man
authors: CM
authors: Hong
authors: Sang Ja
authors: SJ
authors: Ban
authors: Seung Hwa
authors: SH
authors: Hong
mesh_terms: D001681:Biological Assay / Q000592:standards*; D002138:Calibration; D015956:Factor XIIa / Q000032:analysis / Q000737:chemistry / Q000592:standards*; D005260:Female; D006801:Humans; D008297:Male; D012015:Reference Standards; D015203:Reproducibility of Results; D056910:Republic of Korea
chemical_list: D015956:Factor XIIa