Tuberculosis (TB) is a chronic disease caused by the infection of Mycobacte-rium tuberculosis. The number of new cases and deaths from TB is estimated around 8.5 millions (as of 2002) and 1.8 millions (as of 2000), respectively.
Ninety-five per cent of the estimated incidence occurred in developing count-ries and the incidence in Asia, Africa, Middle East and Latin America amountsvto 5 millions, 2 millions, 0.6 millions and 0.4 millions, respectively. Also in developed countries, the pace of reduction in TB incidence has been dropping since the 1980s due to (i) the increased number of elderly and HIV-infected people whose immunities are deteriorated, (ii) the increased number of immi-grants from the countries highly infested with TB, (iii) emergence of multi drug-resistant M. tuberculosis and (iv) social problems such as poverty, increase in the number of homeless people and drug abuse.
In Japan, the number of TB incidence and deaths from the disease in 2005 was 28,319 and 2,295, respectively. TB is still considered a serious disease. In addition, the number of infection with non-tuberculosis mycobacterium (NTM) has been increasing in recent years. An NTM infection may manifest the same symptoms as those of TB. Because many NTM are resistant to ordinary antituberculous drugs, it is critical to distinct NTM infections from TB to determine treatment.
It is possible to treat TB and NTB by an appropriate medication, in addition, to prevent the secondaly infection in community by an appropriate diagnosis. These situations
led to an interest in development of rapidl detection system, resulting in appear-ance of nucleic acid probe-baced identification method and nucleic acid amplification However, these nucleic acid amplification methods require skillful techniques due to complicated pro-cedures, in addition, need precision instrument and special facility. Therefore, a simple and rapid detection system is eagerly wanted.