Australian Government - Department of Health

Medical Services Advisory Committee (MSAC)

1144 - Pathology Tests for Latent Mycobacterial Infection



Application NamePathology Tests for Latent Mycobacterial Infection
Description of Procedure or TestThree tests used in the diagnosis and management of tuberculosis:
  • Nucleic acid Amplification Test (NAAT) for diagnosis of tuberculosis (TB) infection in a person with clinical signs and symptoms of TB
  • NAAT for Mycobacterial infection other than tuberculosis in tissue biopsy with consistent histopathology
  • Quantiferon Gold or other interferon-gamma release immunoassays (IGRAs), as a substitute for Mantoux test (Tuberculin Skin Test, TST), for use in the diagnosis of latent tuberculosis
Advisory PanelDr Graeme Suthers
MSAC member
Genetic Pathologist
Professor Michael Bilous
Deputy Chair
MSAC Member
Anatomical Pathologist
Associate Professor Jim Black
Dr Vitali Sintchenko
Dr Sharon Chen
Royal College of Pathologists of Australasia
Associate Professor Stephen Graham
Mr Keith Williams
Consumer Health Forum Nominee
Date Received by MSAC Secretariat27/10/2009
Stage 1 - EligibilityEligible
Stage 2 - AssessmentAssessment Report - PDF Printable Version (PDF 1,791 KB)
ESC considered this assessment on 9 February 2012.
MSAC appraised this assessment on 29 March 2012.
Public Summary Document - PDF Printable Version (PDF 106 KB)
Stage 3 - Formulation of Advice to the MinisterMSAC advised the Minister that it supports the extension of the current item descriptor for the interferon gamma release assay (IGRA) to include additional subgroups of patients. The final item descriptor should be finalised by the Department in consultation with relevant
groups such as the National Tuberculosis Advisory Committee (NTAC) and then with the
MSAC Executive.

MSAC advised the Minister that the options to extend the item descriptor including the
following subgroups of patients in descending order of the strength of evidence to support the advice from MSAC for that subgroup:
1. patients about to commence long-term immunosuppressive therapy (e.g. tumour necrosis factor [TNF] inhibitors), because it is clinically sensible to perform this assessment before starting long-term treatment with such therapies, rather than waiting until the patient becomes immunosuppressed
2. patients previously vaccinated with the Bacille Calmette Guérin (BCG) vaccine, because this is known to increase the likelihood of a false positive test result with the tuberculin skin test (TST), or Mantoux test, and so the higher specificity of IGRA in BCG-vaccinated patients especially is important
3. patients considered at low risk of latent tuberculosis bacillus infection (LTBI) with a positive TST result, because the evidence of comparative analytical validity between the two test options indicated a significantly lower test positive rate for IGRA without a significantly increased rate of false negatives, leading to a reduction in unnecessary follow-up and unnecessary treatment
4. patients considered at high risk of LTBI with a negative TST result, because the evidence available was not analysed in terms of test negative rates and rates of false positives.

MSAC also advised the Minister that there was an insufficient basis to support any increase in the MBS fee associated with IGRA testing, noting the high proportion of bulk billing for current IGRA testing.
Stage 4 - Noting by Minister
  • advice is not communicated to the Minister until the Minutes of the relevant meeting have been ratified by MSAC members (which may take several weeks)
  • the Minister needs time to properly consider MSAC's advice (and may choose to seek further policy advice from the department before noting the advice)
  • a Government decision to list a service supported by MSAC is taken in the context of other Government priorities: MSAC's support of an application for public funding does not oblige the Government to list the service on the MBS
The Minister noted MSAC's advice 12 June 2012.
Stage 5 - ImplementationIn process