Method and compositions for detection and diagnosis of...

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...

Reexamination Certificate

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C424S009100, C424S009200, C424S009800, C424S248100, C424S810000, C435S030000, C435S253100, C435S286100, C435S287200, C514S772000

Reexamination Certificate

active

06979450

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 andTubercle bacilliinfected guinea pigs, Tubercle and Lung Disease, Jun. 1994, Supp. No. 1(196).
Haga et al. Effective Isolation of MPB64 from a large volume of culture filtrate ofMycobacterium bovisBCG Tokyo, Jpn. J. Med. Sci. Biol, 49: 15-27 (1996).
Haga et al., Delayed-type hypersensitivity to a recombinant mycobacterial antigen, MPB64 in guinea pigs sensitized toMycobacterium tuberculosisorMycobacterium bovisBCG, Journal of Leucocyte Biology, 57: 221-225 (Feb. 1995).
Harboe et al., “Properties of Proteins MPB64, MPB70, and MPB80 ofMycobacterium bovisBCG”, Infection and Immunity, vol. 52, No. 1, p. 293-302, 1986.
Nagai et al., “Specific Skin-Reactive Protein from Culture Fitrate ofMycobacterium bovisBCG”, Infection and Immunity, vol. 31, No. 1, p. 1152-1160, 1981.
Wiker et al., “MPB59, a Widely Cross-Reacting Protein ofMycobacterium bovisBCG”, Int. Archs Allergy appl. Immun., vol. 81, No. 4, p. 307-314, 1986.
Haga, et al.,Difference in Delay Skin Reaction to MPB64 Between BCG-Immunized and Tubercle Baccli-Infected Guinea Pigs, Tubercle and Lung Disease, vol. 75, Supplement 1. p. 54, 28thWorld Conference of IUATLD/UICTMR, Mainz, Germany, Jun. 14-17, 1994.
Haga, et al.,Effective Isolation of MPB64 from a Large Volume of Culture Filtrate of Mycobacterium Bovis BCG Tokyo, JPN. J. Med. Sci. Biol., vol. 49, pp. 15-27 (1996).
Haga et al.,Delayed Type Hypersensitivity to a recombinant mycobacterial antigen, MPB64, in guinea pigs sensitized to Mycobacterium tuberculosis or Mycobacterium bovisBCG,Journal of Leukocyte Biology, vol. 57, pp. 221-225 (1995).
Nakamura, et al.,Tuberculosis Diagnosis with MPB64—Preliminary Study with a human being, “Kekkaku(Tuberculosis)”,The Japanese Society for Tuberculosis,Feb. 15, 1996. Discusses results of preliminary studies conducted to test efficacy of MPB64 Antigen administered to skin surface by way of hydrophilic ointment. Results were inconclusive and ointment was not defined, no translation; only statement of releroncy considered.
Wilcke, et al.,Clinical Evaluation of MPT-64 and MPT-59, two proteins secreted from Mycobacterium tuberculosis, for skin test reagents, Tubercule and Lung Disease, vol. 77, pp. 250-256 (1996).

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