Original Title: Application 1234

Authors' objectives: To conduct a systematic review on nucleic acid amplification testing (NAAT) for the diagnosis of (1) Mycobacterium tuberculosis (MTB) infections in persons with clinical signs and symptoms of tuberculosis (TB), or (2) non-tuberculous mycobacteria (NTM) infections in patients suspected of having an NTM infection.

Authors' recommendations: Effectiveness issues - The two studies that provided direct evidence are likely not generalisable to the Australian setting and the results are probably confounded; therefore, the results are unreliable. - Culture is an imperfect reference standard; thus, a large proportion of false‐positive patients (i.e. NAAT‐positive and culture‐negative) will likely have clinical disease (see 'Comparison of NAAT and culture, using clinical diagnosis as a reference standard'). Economic issues - The cost of NAAT is the main driver of the incremental costs in the economic modelling. Large variations in test cost were observed across Australian pathology providers. - The cost‐effectiveness of NAAT is highly sensitive to reductions in the prevalence of TB in the tested population and reductions in the specificity parameters of NAAT. Financial issues - The population eligible for NAAT may be an overestimate, as the approach used may include patients who are ineligible for NAAT, such as those suspected of Mycobacterium leprae, patients receiving testing across multiple years for the same infection, or patients who do not have clinical signs and symptoms of a mycobacterial infection. - As NAAT is currently being used (the extent of which is uncertain), some shifting of costs from the states to the federal health budget is likely but has not been costed in the financial analyses.

Project Status: Completed

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

Year Published: 2014

URL for published report: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/3338F49EE667C11CCA25801000123BE9/$File/1234_FinalAssessmentReport-accessible.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Adelaide Health Technology Assessment

Contact Address: School of Public Health, Mail Drop 545, University of Adelaide, Adelaide SA 5005, AUSTRALIA, Tel: +61 8 8313 4617

Contact Name: ahta@adelaide.edu.au

Contact Email: ahta@adelaide.edu.au

Copyright: Adelaide Health Technology Assessment (AHTA)