Authors' objectives: 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. 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.

Authors' recommendations: After considering the available evidence presented in relation to safety, clinical effectiveness and cost-effectiveness of nucleic acid amplification testing (NAAT) to diagnose: • mycobacterium tuberculosis (MTB) infections in persons with clinical signs and symptoms of tuberculosis (TB) • non-tuberculosis mycobacteria (NTM) infections in patients suspected of having an NTM infection. MSAC did not support a change in public funding of NAAT because of the uncertain incremental clinical benefit in a poorly defined patient population which made the cost effectiveness indeterminable. MSAC noted that there were certain Australian populations where there may be a more pressing need for rapid diagnosis and management of TB infections and proposed the applicant could consider investigating the clinical efficacy and cost effectiveness in these populations.

Project Status: Completed

URL for project: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1234-public

Year Published: 2015

URL for published report: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/A565E047241617ECCA257C2B001C7FED/$File/1234-Final-PSD-accessible.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medical Services Advisory Committee (MSAC)