title: Establishment of the 2nd Korean national biological reference standard for blood coagulation factor VIII:C concentrate.
abstract: Since the 1st Korean national biological reference standard for factor (F)VIII concentrate, established in 2001, has shown declining potency, we conducted this study to replace this standard with a 2nd Korean national biological reference standard for blood coagulation FVIII concentrate. The candidate materials for the 2nd standard were prepared in 8000 vials with 10 IU/ml of target potency, according to the approved manufacturing process of blood coagulation Factor VIII:C Monoclonal Antibody-purified, Freeze-dried Human Blood Coagulation Factor VIII:C. Potency was evaluated by one-stage clotting and chromogenic methods and the stability was confirmed to meet the specifications during a period of 73 months. Since the potencies obtained by the two methods differed significantly (P < 0.015), the values were determined separately according to the geometric means (8.9 and 7.4 IU/vial, respectively). The geometric coefficients of interlaboratory variability were 3.4% and 7.6% by the one-stage clotting and chromogenic assays, respectively.
authors.affiliation: National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, 187 Osongsaengmyeoung 2-ro, Osong-eup, Cheongju-si 28159, Republic of Korea.
authors.forename: Naery
authors.initials: N
authors.lastname: Lee
authors.affiliation: National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, 187 Osongsaengmyeoung 2-ro, Osong-eup, Cheongju-si 28159, Republic of Korea; Health Policy and Hospital Management, Program in Public Health, Korea University College of Medicine, Anam-dong 5-ga, Seongbuk-Gu, Seoul, Republic of Korea.
authors.forename: Ji Suk
authors.initials: JS
authors.lastname: Seo
authors.affiliation: National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, 187 Osongsaengmyeoung 2-ro, Osong-eup, Cheongju-si 28159, Republic of Korea.
authors.forename: Jae Ok
authors.initials: JO
authors.lastname: Kim
authors.affiliation: National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, 187 Osongsaengmyeoung 2-ro, Osong-eup, Cheongju-si 28159, Republic of Korea. Electronic address: sjban@korea.kr.
authors.forename: Sang Ja
authors.initials: SJ
authors.lastname: Ban
mesh_terms: D001780:Blood Coagulation Tests / Q000379:methods; D005169:Factor VIII / Q000302:isolation & purification* / Q000494:pharmacology / Q000592:standards*; D006801:Humans; D012015:Reference Standards; D056910:Republic of Korea
chemical_list: C078147:F8 protein, human; D005169:Factor VIII
keywords: Blood coagulation FVIII; Chromogenic method; One-stage clotting method; Potency test; Reference standard