RESUMEN
Objective To establish and apply the protein chip to detect eleven autoantibodies profile, and evaluate the authenticity and reliability with ANAs protein chip in clinical autoantibodies profile detection.Methods By comparing the results of IIF and ELISA , validation the sensitivity and specificity of ANAs protein chip in clinical autoantibodies profile detection. The autoantibodies detected were anti-SSA-52,anti-SSA-60,anti-SSB,anti-Sm,anti-RNP,anti-Scl-70,anti-Jo-1,anti-dsDNA,anti-rRNP,anti-centromere antibodies and antinuclear antibodies (ANA). To each autoantibody, we have selected 70 positive and 294 negative samples except the 32 rare samples that contain anti-Jo-1 antibody.Results The sensitivity to all the autoantibodies was 100% except anti-SSA52 and anti-SSB antibodies was 95.7%and 98.6% respectively. The specificity to all the autoanbodies was 100% except anti-SSB, anti-RNP-68, anti-Scl-70, anti-dsDNA, anti-CENP-B and ANA was 98.0%, 98.0%, 99.7%, 99.7%, 99.7% and 98.3% respectively. Conclusions To all the eleven antinuclear autoantibodies , the sensitivity is all above 95.0% and specificity is all above 98.0%, which indicate that there is high concordances between the ANAs protein chip and the methods used in clinical screening and confirmation,and it could meet the requirement of clinical autoantibodies profile detection. The protein chip method is fast, easy for detection with the characteristic of high-throughput,high sensitivity and specificity,it is hence recommended to apply ANAs protein chip to detect autoantibodies profile in clinical detection.