An assessment of nucleic acid amplification testing for active mycobacterial infection

Proposal for public funding

The application did not provide a proposed MBS item descriptor.

Patients with signs and symptoms of active MTB, and patients suspected of having an NTM infection, are two different populations that require different NAATs and different MBS item descriptors. Suggested MBS item descriptors are listed in Table .

Table Suggested MBS item descriptors

Category 6 – PATHOLOGY SERVICES
MBS item number Nucleic acid amplification test for the detection of Mycobacterium tuberculosis complex in patients with signs and symptoms consistent with active tuberculosis. Fee: To be advised
MBS item number Nucleic acid amplification test for the detection of non-tuberculous mycobacteria species in patients with a compatible clinical disease. Fee: To be advised

NAAT to diagnose MTB infections should be conducted on both AFB microscopy positive and negative specimens and on all pulmonary and extrapulmonary specimen types.

NAAT to diagnose NTM infections should be able to detect the most common NTM species associated with pulmonary and extrapulmonary disease, as determined by the state Mycobacterium Reference Laboratories.

NAAT to diagnose NTM infections is intended to be conducted in tissues with granulomatous change in both AFB-positive and -negative specimens, where MTB is not a consideration or has been excluded by an MTB-specific NAAT.

PASC advice is that there should be no limit on the number of tests per year per patient in the MBS item descriptor.

There are a number of NAATs currently listed on the MBS. These range from detection of microbial nucleic acid (item 69494), with a Medicare fee of $28.85, to the amplification and determination of hepatitis C virus genotype (item 69491), with a Medicare fee of $206.20. The application reports that the New South Wales state reference laboratory charges $200 for TB PCR, which is billed to the patient. During the assessment NAAT costs in Australia were found to vary substantially, from $28.65 to $130 or perhaps more if confirmation testing is required. The Victorian reference laboratory⁸ indicated that an in-house NAAT costs $82 and the commercial Xpert kit $130. In this instance the costs are met primarily through the Victorian State Government (only private patients and non-Australian residents are billed for testing).