Methods and compositions for detection and diagnosis of...

Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing – Diagnostic or test agent produces visible change on skin

Reexamination Certificate

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C424S009100, C424S009200, C424S009800, C424S248100, C424S443000, C424S810000, C235S2010FS, C235S2010FS

Reexamination Certificate

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07655218

ABSTRACT:
Methods and compositions for the detection and diagnosis of infectious diseases are provided. In particular, efficient and sensitive methods and compositions for the detection of active mycobacterial disease are provided for distinguishing between individuals having active disease, and individuals who have been immunologically exposed, such as those infected with a mycobacterium but are without active disease, or those who have been vaccinated with BCG. The methods comprise topical application of antigen compositions for transdermal delivery.

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Haga, et al., Difference in Delay Skin Reaction to MPB64 Between BCG-Immunized and Tubercle Baccil-Infected Guinea Pigs,Tubercle and Lung Disease, vol. 75, Supplement 1, p. 54, 28thWorld Conference of IUATLD/UICTMR, Mainz, Germany, Jun. 14-17, 1994.
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Haga et al., Delayed Type Hypersensitivity to a recombinant mycobacterial antigen, MPB64, in guinea pigs sensitized toMycobacterium tuberculosisorMycobacterium bovisBCG,Journal of Leukocyte Biology, vol. 57, pp. 221-225 (1995).
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Wiker et al., “MPB59, a Widely Cross-Reacting Protein ofMycobacterium bovisBCG”, Int. Archs Allergy appl. Immun., vol. 81, No. 4, p. 307-314, 1986.

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