The Biomedical Group of Takara Shuzo Co., Ltd has developed a new reagent kit to rapidly detect Mycobacterium tuberculosis by using its proprietary DNA amplification technology, named ICAN method (Isothermal and Chimeric primer-initiated Amplification of Nucleic Acids). A single cell of the bacterium can be detected within three hours by using the kit.

ICAN method provides an alternative procedure to detect a very small amount of target DNA in a sample with efficiency equivalent to or higher than PCR (Polymerase Chain Reaction) method. In protocol using this kit, nucleic acids are extracted from sputum, and used as a template to isothermally amplify IS6110 gene specific to M. tuberculosis by ICAN method in 96-well plate. The amplified gene is detected by the specific probe. The process, from sampling to detection, requires only three hours, and therefore it makes possible to report the detection results to customers on the same day of sampling. The Group believes this kit is superior to any other detection kits.

Advantages of the kit

1. Results can be obtained within three hours from sampling, and therefore detection reports become available on the same day of sampling . Conventional detection kits using the PCR method take about six hours to obtain results, and it is difficult to report data on the same day.
   
2. The kit has high sensitivity enough to detect the presence of a single cell of the bacterium in samples.
   
3. The gene can be isothermally amplified at 60��. The kit does not require a special device like a thermal-cycler which is needed in PCR method.
   
4. It is possible to check a false negative by an internal standard in the kit.

In addition, when magnetic beads method is employed for the detection system, the kit can be applied to an automated detection device and the operation time can be shortened to 80 minutes. The Biomedical Group has already applied a patent for the developed detection method and will report it at a scientific meeting in August.

This article is translated from the press release in Japanese for your convenience.