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Launch of Cobas TaqMan® 48 Tuberculosis (MTB) assay



          Second qualitative assay on COBAS® TaqMan® test menu


          Real-time PCR technology

          Overall inclusivity rate of 99%

          Sensitive: 10 copies/PCR


It is estimated that between the years 2000 and 2020, the incidence of TB infections will approach one billion people. Of the one billion newly acquired, approximately 200 million people will get ill and 35 million will die, unless greater action is taken to control this disease.
TB affects the greatest number of people in Africa and Southeast Asia. Predictions were made for the demise of TB in industrialized countries by the year 2010. However, recently, TB case rates have risen in several European countries. In the UK and Ireland the estimated burden for TB was 8,113 (at rate of 14.6 per 100,000) adults, respectively in 2006*. Quick and accurate diagnosis is key to effective treatment and patient management, but most MTB case are diagnosed using 100 year old technology.



The COBAS TaqMan® 48 Mycobacterium tuberculosis test kit (Mat No: 04803531190) permits detection of MTB in just 4 hours.


Two features promote fast results. One is the inherent speed of real-time PCR, reducing the turn around time for amplification and detection to 2.5 hours. The other is the user-friendly, kit-based nature of RMD's COBAS TaqMan® 48 kit. The kit is designed with a flexible batch size of 4 vials for 12 reactions each.


The test is specific to the MTB complex identification. Results are available in as little as 4 hours with an overall inclusivity rate of 99%. As all COBAS TaqMan® tests, this test incorporates an Internal control system and contamination is controlled through the inclusion of AmpErase. All this allows for quick decisions on treatment and isolation of patients, and also the quick identification of potentially infected contacts.



Roche Molecular Diagnostics' COBAS® systems standardise, simplify and ensure the reliability of PCR assays, while decreasing the time required for accurate diagnosis of infectious diseases. As a result, physicians can initiate or adjust therapy in a more timely fashion and possibly prevent the spread of infection


* Tuberculosis in the UK, Annual report on tuberculosis surveillance and control in the UK 2007, HPA Report: http://www.hpa.org.uk/publications/2007/TB/TB_annual_report.pdf