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Clinical and Vaccine Immunology, December 2008, p. 1796-1804, Vol. 15, No. 12
1071-412X/08/$08.00+0     doi:10.1128/CVI.00195-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Evaluation of the Recombinant VlsE-Based Liaison Chemiluminescence Immunoassay for Detection of Borrelia burgdorferi and Diagnosis of Lyme Disease{triangledown}

Thomas B. Ledue,1* Marilyn F. Collins,1 John Young,2 and Martin E. Schriefer2

Foundation for Blood Research, Scarborough, Maine,1 Centers for Disease Control and Prevention, Diagnostics and Reference Section, Division of Vector-Borne Infectious Diseases, Ft. Collins, Colorado2

Received 13 May 2008/ Returned for modification 28 July 2008/ Accepted 15 October 2008

Recent efforts to improve the serologic diagnosis of Lyme disease have included the use of a synthetic peptide (C6) that reproduces the sequence of invariable region 6 of VlsE, the variable surface antigen of Borrelia burgdorferi. In the present study, the diagnostic performance of DiaSorin's recombinant VlsE-based chemiluminescence immunoassay in 1,947 human serum samples was evaluated. Sensitivity was determined using two serum panels from the CDC. For panel I, we observed sensitivities of 68.4% and 75.6% for subjects with early, localized (n = 19) or disseminated (n = 41) disease, respectively. For panel II, we observed sensitivities of 61.5% and 100% for subjects with early (n = 26) or late-stage (n = 11) disease, respectively. We observed a specificity of 99.5% for healthy donors (n = 600) living either in regions of the United States where the disease is endemic or in regions where it is not endemic. Overall, specificity among 207 potentially cross-reactive sera from subjects who had other spirochetal infections, nonspirochetal infections including bacterial and viral infections, or autoimmune or neurologic disease; who were positive for rheumatoid factor or anti-mouse antibodies; or who had been previously vaccinated for Lyme disease was 93.7%. In a direct comparison of 1,038 prospectively collected samples for Lyme disease testing we observed a relative sensitivity of 70%, a relative specificity of 99.1%, and an overall agreement of 97.1% between the DiaSorin recombinant VlsE chemiluminescence immunoassay and the Immunetics peptide-based C6 enzyme-linked immunosorbent assay.

* Corresponding author. Mailing address: Foundation for Blood Research, 8 Science Park Road, Scarborough, ME 04074. Phone: (207) 883-4131. Fax: (207) 883-1377. E-mail: tledue{at}fbr.org

{triangledown} Published ahead of print on 22 October 2008.

Clinical and Vaccine Immunology, December 2008, p. 1796-1804, Vol. 15, No. 12
1071-412X/08/$08.00+0     doi:10.1128/CVI.00195-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.





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