Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
2005-01-11
2005-01-11
Swartz, Rodney P (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C424S130100, C424S164100, C424S168100, C424S184100, C424S234100, C435S004000, C435S007100, C435S007320
Reexamination Certificate
active
06841159
ABSTRACT:
An assay method and kit is disclosed for detecting the presence of at least one predesignated, target antibody to a mycobacterium in a sample selected from one or more patient bodily fluids. The method comprises the following steps: (a) contacting the sample of one or more patient bodily fluids with at least one mycobacterium antigen on a lateral-flow assay membrane to bind to the target antibody in the sample; (b) previously, simultaneously or subsequently to step (a), binding the at least one mycobacterium antigen with a conjugated label producing a detectable signal; and (c) detecting the signal whereby the presence of the target antibody is determined in the sample by the intensity or presence of the signal. The method can further comprise the step of evaluating immunization status of the patient from whom the sample came by comparing the signal or lack thereof with immunizations previously received by the patient and in comparison to a known standard control. In a preferred embodiment, the mycobacterium antigen specifically binds toMycobacterium tuberculosisspecific antibodies. Preferably, the immunoassay of the present invention comprises a lateral-flow assay comprising a membrane, a conjugated label pad, and at least one mycobacterium antigen bound to the membrane. In a preferred embodiment, the at least one mycobacterium antigen is selected from the group consisting of 38 kDa and 16 kDa antigens.
REFERENCES:
patent: 4268434 (1981-05-01), Higerd et al.
patent: 4391904 (1983-07-01), Litman et al.
patent: 4458014 (1984-07-01), Ebersole
patent: 4639419 (1987-01-01), Olsen et al.
patent: 4866167 (1989-09-01), Chen et al.
patent: 4965192 (1990-10-01), Maes
patent: 5830410 (1998-11-01), Thieme et al.
patent: 5922614 (1999-07-01), Cesarczyk
patent: 6548309 (2003-04-01), Moore et al.
R. A. Cole, et al., “Clinical Evaluation of a rapid immunochromatographic Assay Based on the 38 kDa antigen ofMycobacterium tuberculosison Patients with Pulmonary Tuberculosis in China”; Tubercle and Lung Disease (1996) 77, p 363-368.
Sudha Pottumarthy et al., “A Comparison of Seven Tests for Serological Diagnosis of Tuberculosis”; Journal of Clinical Microbiology, Jun. 2000, p. 2227-2231.
J.R. Reddy et al., “An immunochromatographic serological assay for the diagnosis ofMycobacterium tuberculosis”; Comparative Immunology, Microbiology & Infectious Diseases 25 (2002) 21-27.
Web site: (http://home.hkstar.com/-granttec
ews.html); “New Serum Test for Tuberculosis”, 1 sheet.
Web site: (http://www.omegadiagnostics.com.uk); “Products”, “The Company”, “TB Disease Background”, “TB Diagnostic Techniques”, “TB Role of TB Serology”, “TB Potential serological applications using 38/16 kDa antigen”, “TB Questions and Answer”; 9 sheets.
Wilkinson R.J., Haslov, K., Rappuoli, R., Giovannoni, F., Narayanan, P.R., Desai, C.R., Vordermeier, H.M., Paulsen, J., Pasvol, G., Ivanyi, J., and Singh, M. Evaluation of the recombinant 38-kilodalton antigen ofMycobacterium tuberculosisas a potential immunodiagnostic reagent.J. Clin. Microbiol.35(3): 553-7. Mar 1997.
Maekura, R., Nakagawa, M., Nakamura, Y., Hiraga, T., Yamamura, Y., Ito, M., Ueda, E., Yano, S., He, H., Oka, S., et al. Clinical evaluation of rapid serodiagnosis of pulmonary tuberculosis by ELISA with cord factor (trehalose-6, 6′-dimycolate) as antigen purified fromMycobacterium tuberculosis. Am. Rev. Respir. Dis.148:997-1001.Oct, 1993.
Young, D., Kent, L., Rees, A., Lamb, J., and Ivanyi, J. Immunological activity of a 38-kilodalton protein purified fromMycobacterium tuberculosis. Infect. Immun.54(1): 177-83. Oct, 1986.
Singh, M., Andersen, A.B., McCarthy, J.E., Rohde, M., Schutte, H., Sanders, E., and Timmis, K.N. TheMycobacterium tuberculosis38-kDa antigen: overproduction inEscherichia coli, purification and characterization.Gene117(1): 53-60. Aug. 1992.
Rosales-Borjas, D.M., Zambrano-Villa, S., Elinos, M., Kasem, H., Osuna, A., Mancilla, R., and Ortiz-Ortiz, L. Rapid screening test for tuberculosis using a 38-kDa antigen fromMycobacterium tuberculosis. J. Clin. Lab. Anal. 12 (2): 126-9. 1998.
Bassey, E.O.E., Catty, D., Kumararatne, D.S., and Raykundalia, C. Candidate antigens for improved serodiagnosis of tuberculosis.Tubercle Lung Dis.77:136-145. 1996.
Kadival, G.V., Chaparas, S.D., and Hussong, D. Characterization of serologic and cell-mediated reactivity of a 38-kDa antigen isolated fromMycobacterium tuberculosis. J. Immunol.139(7): 2447-51. Oct, 1987, (abstract only).
Fujiwara, N., Pan, J., Enomoto, K., Terano, Y., Honda, T., and Yano, I. Production and partial characterization of anti-cord factor (trehalose- 6,6′-dimycolate) IgG antibody in rabbits recognizing mycolic acid subclasses ofMycobacterium tuberculosisorMycobacterium avium. FEMS Immunol. Med. Microbiol.24(2): 141-9. Jun, 1999.
He, H., Oka, S., Han, Y.K., Yamamura, Y., Kusunose, E., Kusunose, M., and Yano, I. Rapid serodiagnosis of human mycobacteriosis by ELISA using cord factor (trehalose- 6, 6′-dimycolate) purified fromMycobacterium tuberculosisas antigen.FEMS Microbiol. Immunol.3(4): 201-4. Aug, 1991.
Enomoto, K., Oka, S., Fujiwara, N., Okamoto, T., Okuda, Y., Maekura, R., Kuroki, T., and Yano, I. Rapid serodiagnosis ofMycobacterium avium-intracellularecomplex infection by ELISA with cord factor (trehalose 6, 6′-dimycolate), and serotyping using the glycopeptidolipid antigen.Microbiol. Immunol.42(10): 689-96.1998.
Chang, Z., Primm, T.P., Jakana, J., Lee, I.H., Serysheva, I., Chiu, W., Gilbert, F., and Quiocho, F.A.Mycobacterium tuberculosis16-kDa antigen (Hsp 16.3) functions as an oligomeric structure in vitro to suppress thermal aggregation.J. Biol. Chem.271:7218-7223. 1996.
Cunningham, A.F., and Spreadbury, C.L. Mycobacterial stationary phase induced by low oxygen tension:cell wall thickening and localization of the 16-kilodalton alpha-crystalline homolog.J. Bacteriol.180(4): 801-8. Feb, 1998.
Hemby, Jr. Joseph K.
Swartz Rodney P
The United States of America as represented by the Secretary of
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