The western immunoblot for Lyme disease: determination of sensitivity, specificity, and interpretive criteria with use of commercially available performance panels.

Abstract

Recent recommendations for the serological diagnosis of Lyme disease include statements on quality assurance and the use of performance panels to assess laboratory competency. We used two performance panels--one from the Centers for Disease Control and Prevention (CDC) and one from Boston Biomedica Inc. (West Bridgewater, MA)-to evaluate the sensitivity and specificity of four western blot kits. We used the same panels to compare the interpretive criteria for western blots as proposed by participants in the Centers for Disease Control and Prevention, Association of State and Territorial Public Health Laboratory Directors Conference and those proposed by BBI Clinical Laboratories (BBICL; New Britain, CT). Our results indicated that the BBICL western blots were more sensitive than those of the CDC, MarDx (Carlsbad, CA), or Cambridge Biotech (Rockville, MD). However, use of the CDC criteria with the BBICL western blots increased specificity to 100% but reduced sensitivity to 74.3%. A sample table is provided as an example of the test results obtained with the BBI performance panel. Obviously, this work should be confirmed by other investigators.