Performance of a commercial immunoassay for detection and differentiation of periodontal marker bacteria: Analysis of immunochemical performance with clinical samples

Background: We employed a commercial immunoassay for simultaneous detection and differentiation of marker bacteria Actinobacillus actinomycetemcomitans, Porphyromonas gingivalls, and Prevotella intermedia and reassessed the immunochemical performance of the assay. Methods: We compared the analytical performance of the immunoassay in our study of clinical samples from 249 periodontal patients in 2 private periodontal practices with the previously reported analytical performance of the same immunoassay. We also compared immunoassay measurements of the marker bacteria in clinical samples with values obtained in other studies by direct culture of the same organisms. Results: The assay produced 3 times more high-end readings than reported previously. We also reassessed and revised previously published calibration curves for the immunoassay. The immunoassay provided measurements of the marker bacteria in clinical samples from our patients that were comparable to and consistent with measurements of the same bacteria by direct culture in other studies. Conclusions: We ascribe the increased sensitivity of the immunoassay in our study to: 1) a more standardized and vigorous sample dispersion that improves release of particulate and soluble antigens from dental plaque biofilm, and 2) better visualization of the reaction product of the enzyme-linked immunoassay. High-technology assays, such as diagnostic immunoassays, have a significant potential for future development in dental diagnosis, because they simplify detection and measurement of biologically important markers such as specific bacteria in clinical samples. Commercial assays also have an important potential for standardization of clinical measurements of biological markers.