Borrelia diagnostics and screening methods

Abstract

The present invention provides methods of detecting Borrelia species in a sample (e.g., a sample from a patient suspected of being infected). In particular, the present invention provides compositions and methods for detecting the presence of Borrelia proteins, nucleic acid sequences encoding these proteins, and subject antibodies to these proteins, where the proteins are selected from those listed in Table 3, including: BB0279 (FliL), BBK19, BBK07, BB0286 (FlbB), BBG33, BBL27, BBN34, BBP34, BBQ42, BBQ34, BBM34, BBN27, and BBH13.

Description

[0001]The present application is a divisional of U.S. patent application Ser. No. 12 / 676,794, filed Jul. 15, 2010, now allowed, which is a §371 U.S. National Stage Entry of International Patent Application No. PCT / US2008 / 075613, filed Sep. 8, 2008, which claims priority to expired U.S. Provisional Application Ser. No. 60 / 970,837, filed Sep. 7, 2007, each of which are herein incorporated by reference.[0002]The invention was made with government support under grant numbers AI24424, AI065359, AI072872, LM007743, and AR20358 awarded by the National Institutes of Health, and grant number MRI EIA-0321390 awarded by the National Science Foundation. The government has certain rights in the invention.FIELD OF THE INVENTION[0003]The present invention relates to method of detecting Borrelia species in a sample (e.g., a sample from a patient suspected of being infected). In particular, the present invention provides compositions and methods for detecting the presence of Borrelia proteins, nucle...

AI Technical Summary

Problems solved by technology

Direct detection of the organism by cultivation, histology of a biopsy, or by an approved and validated polymerase chain reaction assay is generally preferable to serological assays for definitive confirmation of a clinical diagnosis but these procedures are uncommon in practice and not likely become widely used for the foreseeable future.

But in the absence of a skin rash (˜20-30% of cases) diagnosis of early Lyme disease solely based on clinical and epidemiologic features is more difficult.

One drawback of the 2-tiered, sequential test procedure is the time it takes and the greater expense for two assays.

Another problem with whole cell assays is a lack of standardization between tests of different manufacturers.

But in other, more recent studies, including some from Europe, either the specificity or sensitivity of single antigen assays was not as good as tests based on two or more antigens or a 2-tiered procedure (Peltomaa, 2004; Marangoni, 2005; Goettner, 2005).

Perhaps the most important problem with currently available whole cell-based assays is that they utilize for their substrates bacteria that have been grown in vitro.

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