- Status Complete
- Type New application
- Pre-PASC consultation -
- Pre-MSAC consultation -
- Outcome Not supported
Application details
Reason for application
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Service or technology in this application
This application is for Nucleic Acid Amplification Tests (NAAT) for the diagnosis and management of tuberculosis (TB) infection, in a person with clinical signs and symptoms of TB or NAAT for the diagnosis and management of mycobacterial infection other than TB in tissue biopsy with consistent histopathology.
Medical condition this application addresses
Tuberculosis usually attacks the lungs but can also affect other parts of the body. Common symptoms include a chronic cough (sometimes accompanied by haemoptysis), fever and night sweats, loss of weight and feeling generally tired and unwell. TB is transmitted mainly by inhalation of infectious droplets produced by persons with pulmonary or laryngeal tuberculosis during coughing, laughing, shouting, singing or sneezing. Rarely, invasion of M. tuberculosis may occur through mucous membranes or damaged skin. Extra-pulmonary tuberculosis, other than laryngeal, is generally not communicable, although can be associated with pulmonary tuberculosis.
Most infections in humans result in an asymptomatic, latent infection. In the immunocompetent host, subsequent progression to active TB occurs in only 5–10 per cent of those infected. This progression can occur from weeks to decades later although half will occur within two years from initial infection. Infection with the M. tuberculosis complex (responsible for most cases) without disease can persist for a lifetime. Active disease if left untreated kills more than 50% of those infected.
Application documents
PICO confirmation
Assessment report
Public summary document
Public summary document
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Meetings to consider this application
- PASC meeting:
- 12 to 13 December 2013
- 16 to 17 April 2014
- ESC meeting: 12 to 13 February 2015
- MSAC meeting: 1 to 2 April 2015