An assessment of nucleic acid amplification testing for active mycobacterial infection



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tarix04.01.2022
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Rationale for assessment


Douglass Hanly Moir Pathology Pty Ltd has submitted an application to the Department of Health that requests listing on the Medicare Benefits Schedule (MBS) of nucleic acid amplification testing (NAAT) to diagnose (1) Mycobacterium tuberculosis (MTB) infections in persons with clinical signs and symptoms of tuberculosis (TB), or (2) non-tuberculous mycobacteria (NTM) infection in patients suspected of having an NTM infection.

The public funding questions addressed in this contracted assessment of NAAT are largely consistent with the approach pre-specified in the protocol that was ratified by the Protocol Advisory Subcommittee (PASC). In the evidence collated for this assessment there were no studies with patients who presented with the clinical signs and symptoms of active TB but for whom it was not possible to obtain a specimen suitable for acid-fast bacilli (AFB) microscopy. Therefore, there were no data available to address the clinical management algorithm proposed in Figure (see ‘Clinical pathway’), and therefore this clinical indication has not been considered further. It should also be noted that the NTM population eligible for NAAT has been expanded from that specified in the protocol, in order to include all patients suspected of having an NTM infection.



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