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Journal of Clinical Microbiology, January 2002, p. 193-197, Vol. 40, No. 1
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.1.193-197.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Recombinant Assay for Serodiagnosis of Lyme Disease Regardless of OspA Vaccination Status

Brook Biotechnologies, Inc., Stony Brook, New York 11790-3350,¹ Division of Infectious Diseases, Department of Medicine, New York Medical College, Valhalla, New York 10595,² Centers for Disease Control and Prevention, Ft. Collins, Colorado 80522,³ Wampole Laboratories, Cranbury, New Jersey 08512-0181,⁴ Department of Medicine, State University of New York at Stony Brook, Stony Brook, New York 11794-8161⁵

Received 20 June 2001/ Returned for modification 23 September 2001/ Accepted 14 October 2001

All current seroassays using cultured Borrelia burgdorferi as their antigen source have been rendered obsolete by the recombinant OspA Lyme disease vaccine. OspA is the major outer surface protein expressed in cultured B. burgdorferi, and any seroassay that uses whole organisms as its antigen source cannot differentiate between subjects who received the vaccine and those who were naturally infected. We developed a new sensitive and specific enzyme-linked immunosorbent assay (ELISA) utilizing recombinant chimeric borrelia proteins devoid of OspA (rNon-OspA) that can be used to detect antibodies to diagnostically important B. burgdorferi antigens in both OspA-vaccinated and nonvaccinated individuals. We tested sera from patients with Lyme disease and with conditions associated with false-positive serologies, OspA-vaccinated individuals, and healthy high-risk workers from an area of endemicity and normal sera from individuals from areas of nonendemicity. The rNon-OspA test was compared with two commercially available whole-cell immunoassays. The rNon-OspA assay is as sensitive and specific as the whole-cell assay (P > 0.05) for detection of anti-B. burgdorferi antibodies. However, the rNon-OspA assay can differentiate between populations comprised of naturally infected and OspA-vaccinated individuals (P < 0.05). Our data demonstrate that this new sensitive rNon-OspA ELISA can be used for the laboratory detection of B. burgdorferi antibodies regardless of vaccination status and could replace existing serologic assays for Lyme disease.

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