Rifampicin (rifampin ) is most important drug in treatment of tuberculosis and it is given as first line of drug therapy and is required to be taken by a patient affected for almost up to 6 months. And it will not provide any beneficial effect incase Mycobacterium tuberculosis strain found in patient is resistant to drug Rifampicin, rather it will impart greater resistance to strain against anti TB antibiotics making it difficult to treat .
With conventional methods it takes about 30 to 90 days to know that Mycobacterium tuberculosis strain found in patient is resistant to antibiotic Rifampicin. (rifampin ) by the time patients health get affected beyond control.
To over come this US FDA approved novel diagnostic test which can detect presence of Mycobacterium tuberculosis infection as well as it can detect if the strain found in patient is resistant to antibiotic Rifampicin.(rifampin ) so that a second line of drug for treatment can be give from the beginning of the therapy.
Xpert MTB/RIF Assay system make use of polymerase chain reaction and detect mutations in RNA polymerase beta (rpoB) gene responsible for antibiotic resistance. And identify DNA specific to Mycobacterium tuberculosis. Xpert MTB/RIF Assay gives result in two hours.
US FDA approved Xpert MTB/RIF Assay under de novo classification process for some low- to moderate-risk medical devices.