This assessment uses the theoretical framework outlined in the MSAC Guidelines for the assessment of diagnostic technologies (MSAC 2005).
This means that evidence of the clinical effectiveness of diagnosing MTB or NTB using NAAT requires either:
evidence of the effectiveness of NAAT from high-quality comparative studies evaluating the use of NAAT and subsequent treatment, compared with culture plus DST and treatment (direct evidence). RCTs provide the highest quality evidence for this comparison; or, if this is not available:
evidence of treatment effectiveness from high-quality comparative studies evaluating the change in management for TB, linked with applicable and high-quality evidence of the accuracy of NAAT to diagnose MTB or NTM, compared with culture plus DST. This is called ‘linked evidence’.
There was limited direct evidence available that met all the inclusion criteria that assessed the safety and effectiveness of NAAT in the diagnosis of MTB or NTB infections.
