[MBL quality control survey of autoantibodies--25 years of activity and its achievement--mainly antinuclear antibodies].
Annual MBL Quality Control Survey of Autoantibodies has continued to this day since it started in 1983 as the only quality control survey of autoantibodies in Japan. The survey has aimed at unification and standardization of measurement value, as well as finding out between-laboratory differences in results through reporting the results of tabulation to the participating laboratories. For carrying out the survey, we intend to make our efforts to promote assurance and standardization of the quality control of the autoantibodies. The number of participant on this survey has been increasing every year and more than 500 laboratories participate not only in Japan but also from Asia and European countries. The laboratories that participated in this survey are the ones that usually perform ANA test, anti-DNA antibodies test, anti-ENA antibodies test, AMA test, ASMA test, anti-cardiolipin antibodies test and anti-CCP antibodies test. The purpose of the survey is to standardize antinuclear antibodies testing value in semi quantitative assay using ANA control serum or our titer control HEPASERA-1. We got 12% increase from 79% to 91% in 1986 using ANA control serum. Additionally, we reached 97% (86% to 97%) of convergence in 2001 by using HEPASERA-1, which contains 4 major pattern titer controls from 1993. In 2007, coefficient of variation (CV) for anti-dsDNA antibodies was 13%, showing better result than 25% of the first survey in 1993. We started secondary survey for laboratories which reported a result far apart. In the secondary survey, we made investigation for cause and improvement action. We conclude quality control survey is useful for autoantibodies testing for its result convergence.
Tsunekawa
Shinji
S
Medical & Biological Laboratories Co., Ltd, Ina 396-0002, Japan. tsunekawa.shinji@mbl.co.jp
Arai
Jiro
J
Ishihara
Yasushi
Y
Fujii
Yoshihisa
Y
D000974:Antibodies, Antinuclear / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards*; D005455:Fluorescent Antibody Technique / Q000592:standards*; D006801:Humans; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards
D000974:Antibodies, Antinuclear; D011933:Reagent Kits, Diagnostic