Japanese collaborative study for fibrinogen assay: variability of the fibrinogen assay between different laboratories does not improve when a common calibrator is used

Authors: TAKAMIYA, O.¹; HANDO, S.²; TEKONDO, M.³; BANDO, S.⁴; OHKURA, M⁵; NEGORO, T.⁶; YOSHIDA, T.⁷; HIGASHI, K.⁸; OHNUMA, O.⁹; KUBOTA, K.¹⁰; TATSUMI, N.¹¹

Source: Clinical & Laboratory Haematology, Volume 27, Number 3, June 2005 , pp. 177-183(7)

Publisher: Blackwell Publishing

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Abstract:

Summary

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.

Keywords: Clauss method; common calibrator; external quality control; fibrinogen

Document Type: Research article

DOI: 10.1111/j.1365-2257.2005.00686.x

Affiliations: 1: Department of Biomedical Laboratory Sciences, School of Health Sciences, Shinshu University, Matsumoto Asahi, Japan 2: Clinical Laboratory, Matsumoto Dental University Hospital, Matsumoto, Japan 3: Department of Medical Laboratory, Urasoe General Hospital, Urasoe, Japan 4: Laboratory Division of Ehime University Hospital, Shigenobu, Japan 5: Department of Clinical Laboratories, Kawasaki Medical School Hospital, Kawasaki, Japan 6: Central Clinical Laboratory, Rinku General Medical Center, Isumisano, Japan 7: Central Clinical Laboratory, Kanazawa University Hospital, Kanazawa, Japan 8: Clinical Laboratory, Faculty of Medicine, University of Tokyo, Tokyo, Japan 9: Clinical Laboratory, Yamagata University School of Medicine, Yamagata, Japan 10: Department of Clinical Laboratory, Asahikawa Medical College, Asahikawa, Japan 11: International Buddhist University, Osaka, Japan

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