A critical evaluation of enzyme immunoassays for detection of antinuclear autoantibodies of defined specificities. I. Precision, sensitivity, and specificity.

摘要: Objective To determine the performance characteristics of enzyme-based immunoassay (EIA) kits for detection antinuclear and other autoantibodies defined specificities. Methods Nine manufacturers EIA to detect antibodies specificities participated in a study which they received coded sera from Centers Disease Control Prevention. These contained different dilutions antibody one specificity mixed with containing specificities. The were asked use their standard technology content send data committee International Union Immunological Societies analysis. analyzed sensitivity anti–double-stranded DNA (anti-dsDNA), anti–single-stranded DNA, antihistone, anti-Sm, anti–U1 RNP, anti-SSA/Ro, anti-SSB/La, anti–Scl-70 (DNA topoisomerase I), anticentromere, anti–Jo-1 antibodies. In addition, replicate samples included evaluate precision each method. Results Lack was most evident anti-dsDNA anti-Sm kits, although 2 achieved acceptable specificity. Generally, anti–Scl-70, performed well. Many false-positive results obtained multiple myeloma serum cryoprecipitates, but without cryoprecipitates presented no problem system. Precision, based on evaluation samples, varied very good poor. Conclusion No single manufacturer clearly superior others terms products' overall sensitivity, specificity, precision. Areas that needed improvement dsDNA Sm antigen. Some Individual informed respective so could take measures correct perceived deficiencies thus improve reliability group important diagnostic assays used systemic rheumatic diseases.