The results of quality control of national autoantibody testing in 2010 / 中华风湿病学杂志

ABSTRACT

Objective To investigate the quality of autoantibody testing around the whole country.Methods Laboratories that perform autoantibody testing were recruited by letters or telephone communications.The auto-antibodies examined by the quality-control survey included anti-nuclear antibody (ANA),anti-double-stranded DNA (anti-dsDNA) antibody,anti-extractable nuclear antigens (anti-ENA),antimitochondria antibody (AMA),anti-smooth muscle antibody (ASMA),and anti-citrulline antibody (CCP).Each autoantibody was tested for 3 samples,so 15 samples were tested in total.Sample distribution and data analysis were double-blinded.Qualitative interpretation,staining patterns were evaluated by IIF.The agreement with qualitative interpretation for each specimen was evaluated by ELISA,and Immuno-Blot/Dot-Blot.Results One hundred and eight laboratories participated in this study.The testing methods included indirect immumofluorescence (IIF),immuno-Blot (IB),Dot-Blot (DB),double diffusion method (DID),enzymelinked immunosorbent assay (ELISA),chemo-illuminescent assay,Dot-immunogold filtration assay.The accuracy rates were 82％,83％,95％,96％,86％,respectively for ANA,anti-dsDNA,AMA,ASMA,and anti-CCP antibody.Anti-ENA were further divided into anti-SNP,anti-Sm,anti-SSA,anti-SSB,anti-Scl-70 subgroups,and the accuracy rates were 84％,95％,98％,98％,88％,respectively.The distribution of quantitative values by different laboratories for ANA (by IIF),anti-dsDNA,anti-CCP antibody (by ELISA) varied remarkably.Conclusion Hospitals that enrolled in the survey and the items involved for quality control were increasing year by year.The accurate rates of ANA,anti-dsDNA in this survey were similar to the past national quality control surveys,the quality of AMA/ASMA,anti-CCP antibodies test was better than that of the past surveys,but the quality of anti-ENA antibodies test needs to be improved.