Abstract:

Objective To evaluate the consistency of commonly-used 2 systems for the determination of antinuclear antibody（ANA） profile,and to provide a reference for choosing methods for ANA profile determination. Methods Sera from 358 patients with systemic lupus erythematosus（SLE）,147 patients with autoimmune disease and 47 healthy subjects were collected,and were determined for ANA profile by 2 systems,HUMAN（Germany） Diagnostics Ltd. and EUROIMMUN（China） Medical Diagnosis Ltd.. The calculated consistency and McNemar test were used to evaluate the consistency of 2 systems. Results The consistencies of anti-Smith（Sm） antibody,anti-ribosomal protein（RIB） antibody and anti-ribonucleoprotein（RNP） antibody were 79.9%,93.5% and 82.4%,with statistical significance（P<0.001）. The consistencies of other 4 indices[anti-Sjogren syndrome A（SS-A） antibody,anti-Sjogren syndrome B（SS-B）antibody,anti-scleroderma 70（Scl-70） antibody and anti-Jo-1 antibody] were >90%,without statistical significance（P>0.05）. Among 358 SLE patients,the positive rates of anti-Sm antibody were 48.6% by HUMAN and 27.1% by EUROIMMUN. Among 194 non-SLE patients,the specificities of anti-Sm antibody were 93.3% by HUMAN and 99.5% by EUROIMMUN.Conclusions The consistencies of HUMAN and EUROIMMUN in determining anti-Sm,anti-RIB and anti-RNP antibodies are low,while the other 4 indices show good consistencies. For the determination of anti-Sm antibody,HUMAN reveals a better determination rate and lower specificity than EUROIMMUN.

Key words: Antinuclear antibody, Immunoblotting, Comparison, Consistency