Tuberculosis is a bacterial disease spread by infectious airborne droplets containing Mycobacterium
tuberculosis (MTB). It is estimated by the World Health Organisation (WHO) that approximately one third of the world’s population is infected with M. tuberculosis, resulting in 9 million new cases of TB each year, leading to 3 million deaths annually.

Tuberculosis remains a global public health problem. In many countries diagnosis relies on traditional methods which are either slow or labour intensive.

FASTplaqueTB:  is a rapid and sensitive diagnostic test that can improve TB case detection. Based on a bacteriophage technology the assay detects Mycobacterium tuberculosis complex in clinical specimens. The target mycobacterial cells are rapidly infected by the target-specific bacteriophage which continue to replicate until new progeny phage are released as the cells break open. These progeny bacteriophage are then amplified by the introduction of a rapid growing mycobacterial cell host. Progeny bacteriophage then undergo rapid cycles of infection, replication and lysis, which are seen as plaques in a lawn of confluent host cells. The number of plaques generated from a given sample is related to the number of viable MTB cells containing mycobacteriophage.

Riframpacin is a critical drug in short course chemotherapy for TB. Rifampicin resistance rarely occurs in isolation, and is usually found in combination with isoniazid resistance. Resistance to at least these two key drugs is termed multi-drug resistant tuberculosis (MDR-TB). MDR-TB is an increasing health risk and a threat to TB control programmes in many countries. Treatment of MDR-TB requires use of less effective, more toxic and expensive drugs for longer periods. Delay in diagnosing patients with MDR-TB leads to poorer prognosis for the individual patient and ongoing transmission of the disease.

FASTplaque-Response: is a rapid test, also based on bacteriophage technology, to determine riframpacin resistance in TB directly from sputum in 2 days. Using the FASTplaque principle, the sample is first incubated in the presence or absence of rifampicin before following a similar protocol. The number of plaques in the rifampicin-free sample is compared with the number of plaques produced from the sample incubated in the presence of rifampicin. The presence of plaques in the rifampicin-containing sample indicates that viable MTB have survived and the strain is resistant to rifampicin.

Key Features:

• Rapid results within 48 hours
• Sensitive and specific
• Detects viable TB bacilli
• Simple, manual method - no specialised equipment needed
• Visual readout

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