Analyses of the external quality assessment of autoantibodies testing from 102 laboratories in 2009 in China / 中华检验医学杂志

ABSTRACT

ObjectiveTo evaluate and improve the quality of autoantibodies testing in China.Methods 102 laboratories participated voluntarily in the survey of the quality of autoantibodies testing in October 2009 and received a total of 15 samples from Japan MBL company including 5 different assaysantinuclear antibody ( ANA),anti-double strain DNA (dsDNA) antibody,anti-extractable nuclear antigen (ENA) antibody,anti-mitochondrial antibody ( AMA),anti-smooth muscle antibody ( ASMA ) and anti-cyclic citrollinated peptide (CCP) antibodies.There were 3 samples for each assay.The samples were detected by routine methods.The results were reported with qualitive results (for all),titer (for ANA,antidsDNA antibody and AMA/ASMA),patterns (for ANA) and methods.At the same time,MBL company also distributed the samples to the laborotories in the other areas,Greece,Italy,Japan,Korea,Portugue and China Taiwan,respectively.The results from the other areas were analyzed by MBL company.The results from China were analyzed in our laborotories.The distribution of samples and analysis of testing results was double-blinded.Descriptive analysis were performed with Excel.Only descriptive analysis of the qualitiveresult,positive rate (laboratories that all three results were right/laboratories that took part in the relevant autoantibody detection) were done,and quantity results were set as reference.Results According to the standard results from the analysis of MBL company the rate of satisfied results of ANA,anti-dsDNA antibody,AMA,ASMA,anti-ENA antibody and anti-CCP were 80.8％ ( 80/99 ),81.2％ ( 78/96 ),86.3％ (44/51),76.3％ (29/38),95.9％ (93/97) and 93.1％ (67/72),respectively.The accuracy rate of the titer for ANA was low and related results of sample 901 and 902 were 12.7％ (11/79) and 7.6％ (6/79),respectively.Also a considerable discrepancy was found in the results of anti-CCP among different laboratories using different commercial kits.The ranges of sample 921 and 923 were 10.0-419.0 U/ml and 15.3-418.5 U/ml,respectively.Conclusions The accuracy rates of the rate of satisfied results among ANA,anti-dsDNA antibody,AMA,and ASMA were lower than 90％,however,it's satisfed that the rate is higher than 90％ in anti-ENA antibody and anti-CCP.Internal quality control of ANA titer,AMA and ASMA,and external quality assurance of anti-CCP should be improved.