title: Japanese collaborative study for fibrinogen assay: variability of the fibrinogen assay between different laboratories does not improve when a common calibrator is used.
abstract: Several national and local external quality assurance schemes have been developed to improve the plasma fibrinogen assay in Japan over the past 30 years. Now most commercial calibrant plasma may be calibrated against an International Standard preparation, in order to achieve agreement of results obtained by different laboratories. However, we have never achieved satisfactory results, according to an external quality control survey regarding the fibrinogen assay. Therefore, we distributed two kinds of fibrinogen standards to be used as common calibrators, along with three plasma samples, among 183 general laboratories in Japan. The results of this collaborative study showed that the assigned value for the commercially available calibrators remained problematic. Furthermore, it was concluded that the between-laboratory variability could not be improved beyond a certain degree of standardization, even if a common calibrator was used for the Clauss-derived assay carried out by an automatic coagulometer.
authors.affiliation: Department of Biomedical Laboratory Sciences, School of Health Sciences, Shinshu University, Matsumoto Asahi, Japan. itosamu@gipac.shinshu-u.ac.jp
authors.forename: O
authors.initials: O
authors.lastname: Takamiya
authors.forename: S
authors.initials: S
authors.lastname: Hando
authors.forename: M
authors.initials: M
authors.lastname: Tekondo
authors.forename: S
authors.initials: S
authors.lastname: Bando
authors.forename: M
authors.initials: M
authors.lastname: Ohkura
authors.forename: T
authors.initials: T
authors.lastname: Negoro
authors.forename: T
authors.initials: T
authors.lastname: Yoshida
authors.forename: K
authors.initials: K
authors.lastname: Higashi
authors.forename: O
authors.initials: O
authors.lastname: Ohnuma
authors.forename: K
authors.initials: K
authors.lastname: Kubota
authors.forename: N
authors.initials: N
authors.lastname: Tatsumi
mesh_terms: D002138:Calibration; D005340:Fibrinogen / Q000032:analysis* / Q000592:standards; D006801:Humans; D007564:Japan; D007753:Laboratories / Q000592:standards* / Q000706:statistics & numerical data; D010949:Plasma; D011786:Quality Control; D012680:Sensitivity and Specificity
chemical_list: D005340:Fibrinogen