Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Reexamination Certificate
2002-01-30
2004-11-09
Horlick, Kenneth R. (Department: 1637)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
C435S091200, C435S810000, C536S022100, C536S024330
Reexamination Certificate
active
06815165
ABSTRACT:
BACKGROUND OF THE INVENTION
This application claims priority to the foreign application KR 2001-43450 filed Jul. 19, 2001.
FIELD OF THE INVENTION
The present invention relates to a method for identifying
Mycobacterium tuberculosis
(hereinafter, referred to as ‘
M. tuberculosis
’) and
Mycobacterium
Other Than Tuberculosis (hereinafter, referred to as ‘MOTT’), and for the determination of resistance of
M. tuberculosis
to an antituberculosis drug obtained by the mutation of the rpoB gene.
DESCRIPTION OF THE RELATED ARTS
Tuberculosis is a chronic wasting disease caused by
M. tuberculosis
. Worldwide, it ranks the first in mortality and morbidity among infectious diseases (Global Tuberculosis Programme. Global Tuberculosis Control, WHO Report 1997. World Health Organization, 1997). Carriers of
M. tuberculosis
presently number about 1.9 billion, a third of the world population, and about 8-10 million of these carriers develop into new tuberculosis patients per year, and about 3 million of patients die of tuberculosis per year (Dolin P. J., Raviglion M. C., Kochi, A. (1994) Global tuberculosis incidence and mortality during 1990-2000. Bull World Health Organization. 72(2): 213-220; Kochi, A. (1992) The global tuberculosis situation and the new control strategy of the World Health Organization.
Tubercle
. SCI. 72:1-6; Styblo K. Epidemiology of Tuberculosis the Hague, Royal Netherland Tuberculosis Association (1991), p. 83 in: Minister of Health and Welfare, The Korean National Tuberculosis Association. Measures for Tuberculosis Control in 2000s, p5, 1997). Also, about a half of the population in Korea are carriers of
M. tuberculosis
, and about 150,000 persons develop into new tuberculosis patients per year, and about 14,000 patients per year die of tuberculosis (Sreevatsan S. Stockbauer K E, Pan X, Kreiswirth B N, Mogha S L, Jacobs W R Jr, Telenti A, Musser J M. (1997) Ethambutol resistance in
M. tuberculosis
: critical role of embB mutations.
Antimicrob Agents Chemother
41:1677-1681).
Recently, it was reported that patients doubly infected with HIV virus and
M. tuberculosis
are much more susceptible to tuberculosis. The seriousness of the problem of tuberculosis has become increasingly apparent, together with the increase of HIV in the world as well. Presently, it is estimated that about 15 million patients are double infected by both the
M. tuberculosis
and HIV. Also, most of these patients will probably develop into fulminant tuberculosis patients, which will lead to their deaths (Narain J. P., Raviglione M. C., Kochi A. (1992) HIV-associated tuberculosis in developing countries: epidemiology and strategies for prevention.
Tuber Lung Dis
. SCI. 73(6): 311-321).
The insufficiency of the present antituberculosis drugs and improper treatment and control of tuberculosis in these developing countries results in the increase of patients with
M. tuberculosis
which are the resistant to antituberculosis drugs (Global Tuberculosis Programme. Anti-tuberculosis drug resistance, WHO Report 1997. World Health Organization, 1997). The increasing appearance of resistant
M. tuberculosis
has resulted in the concomitant increase in tuberculosis related mortality and has obstructed attempts to eliminate it from a population (Ariel, P. M., M. C. Raiglion, A. Laszlo, N. Binkin, H. L. Rieder, F. Buster, D. L. Cohn, C. S. B. L. van weezenbeck, S. J. Kim, P. Chaulet, P. Nunn. (1998) Global surveillance for antituberculosis-drug resistance.
New England J. of Medicine
. SCI. 338:1641-1649; Centers for Disease Control. (1992) National action plan to combat multidrug-resistant tuberculosis. Morb Mortal Wkly Rep 41(RR-11):5-48; Global Tuberculosis Programme. Global project on Anti-tuberculosis Drug Resistance Surveillance. WHO Report 1997. World Health Organization, 1997; Tuberculosis: A Global Emergency (news). World Health Forum, 14(4):438, 1993. In: Minister of Health and Welfare, The Korean National Tuberculosis Association. Measures for Tuberculosis Control in 2000s, 1997). In the meantime, current treatment of resistant
M. tuberculosis
is quite costly and has low efficiency, thus the resistant mycobacteria often develops into incurable tuberculosis. Therefore, earlier diagnosis of resistant
M. tuberculosis
should result in more efficient treatment of tuberculosis patients.
In most countries, including Korea, the drug-susceptibility test for
M. tuberculosis
is performed using standard microbiological methods, which require long time periods of 8-10 weeks to grow
M. tuberculosis
in culture (Index of Korean Health and Welfare in 1996, p. 412, Korea Institute for Health and Social Affair, 1997). Therefore, methods for rapidly and accurately detecting the drug susceptibility of the infecting
M. tuberculosis
are needed. Rapid diagnosis of resistant mycobacteria may increase the efficiency of the tuberculosis treatment because it may provide proper treatment strategies earlier in the development of the disease. Ultimately, rapid diagnostic methods may slow the increase of incurable tuberculosis resulting from infection with drug-resistant
M. tuberculosis
. Therefore, such diagnostic methods are important health care technologies capable of decreasing further economic loss by prevention, elimination and treatment of tuberculosis.
Recently, the mechanism of drug-resistance was discovered by the use of genetic-based technology. For example, it is reported that the mechanism by which
M. tuberculosis
obtains resistance to rifampin, one of the strongest effective antituberculosis drugs, results from a nucleotide mutation in the 69bp region of the gene which encodes the &bgr;-subunit of RNA polymerase (rpoB gene) (Telenti A., Imboden P., Marchesi F., Lowrie D., Cole S., Colston M. J., Matter L., Schopfer K., Bodmer T. (1993) Detection of rifampicin-resistance mutation in
Mycobacterium tuberculosis. Lancet
. SCI. 341:647-50; Vareldzis B. P., Grosset J., de kantor I., Crofton J., Laszlo A., Felten M., Raviglione M. C., Kochi A. (1994) Drug-resistant Tuberculosis: Laboratory Issues, World Health Organization Recommendations.
Tuber Lung Dis
. SCI. 75(1):1-7). At least 97% of
M. tuberculosis
with resistance to rifampin is due to the above mutation.
The genus
Mycobacterium
includes, in addition to
M. tuberculosis, M. lepraeae
(Hansen's disease or Leprosy) and other
Mycobacterium
species generically called
Mycobacterium
Other Than Tuberculosis (hereinafter, referred to as ‘MOTT’). MOTTs are mycobacteria which cause opportunistic infections, and thus MOTTs generally infect patients who have reduced immunity; however, normal persons can be infected on occasion. Since 1980, most of the industrialized nations have reported that MOTTs cause tuberculosis in HIV patients. Further, the number of diseases found to be caused by MOTTs has been increasing, so that the rapid and accurate identification of mycobacterial species has been recognized as being important for health care providers.
Conventional methods for identifying
M. tuberculosis
and MOTTs are based on various microbiological and biochemical properties of
Mycobacterium
species (Kochi A., Vareldzis B., Styblo K. (1993) Multidrug-resistant tuberculosis and its control.
Res Microbiol
. SCI. 144(2):104-110). However, such conventional identifications require for up to four weeks of growth time, depending on the types of mycobacteria, thus the identification time is prolonged. In addition, the results obtained by the conventional methods are sometimes unclear, and some
Mycobacterium
species cannot be distinguished from other species with these conventional methods. Therefore, to overcome the above problems of the conventional identifications, the identification of MOTTs using molecular biological methods has been recently developed.
Particularly, methods for the molecular biological identification of MOTTs using as its target, a highly conserved genetic domain in all mycobacterial species, were developed (Timpe A, Runyon E H: The relationship of “atypical” acid-fast bacteria to human disease: A preliminary report.
J
Bai Gill-Han
Bang Hye Eun
Cho Sang-Nae
Kim Sang-Jae
Lee Hyeyoung
Cho Sang-Nae
Horlick Kenneth R.
Nixon & Vanderhye P.C.
Tung Joyce
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