 |
|
|
 |
A Critical Evaluation of Enzyme Immunoassay Kits for Detection of Antinuclear Autoantibodies of Defined Specificities. II. Potential for Quantitation of Antibody Content ENG M. TAN, JOSEF S. SMOLEN, J. STEVEN McDOUGAL, MARVIN J. FRITZLER, THOMAS GORDON, JOHN A. HARDIN, JOACHIM R. KALDEN, ROBERT G. LAHITA, RAVINDER N. MAINI, WESTLEY H. REEVES, NAOMI F. ROTHFIELD, YOSHINARI TAKASAKI, ALLAN WIIK, MERLIN WILSON, and JAMES A. KOZIOL
ABSTRACT. Methods. Twenty companies that were known major purveyors of EIA kits for detection of ANA were approached to determine their interest and willingness to participate in this study. The manufacturers were advised that they would be sent coded sera containing mixtures of the Arthritis Foundation/Centers for Disease Control reference reagents, and that they were to use their own test kits to analyze the antibody specificities of these sera and to report the data, in optical density (OD) units, or their equivalent. The analysts were blinded to the concentration of the antibodies and the specificities.
Results. Initially, 11 manufacturers out of 20 agreed to participate, but 2 subsequently withdrew. The commercial EIA kits have the potential of being able to quantitate specific autoantibody content to ds-DNA, SSB/La, Sm, and Scl-70. However, certain deficiencies in these kits were also detected, the most obvious being lack of uniformly good performance, with kits of certain manufacturers showing exceptional accuracy in 3 out of 4 of their antibody-specific kits and poor accuracy for a 4th kit.
Key Indexing Terms:
AUTOANTIBODIES
|