Tuberculosis
The applicant proposed that patient outcomes will differ according to the pre-test probability of a patient having TB. Patients with a high pre-test probability of having TB commence antibiotic treatment immediately (i.e. prior to diagnostic confirmation); therefore, NAAT will have limited impact on patient management. In patients at risk of active TB it is proposed that the use of NAAT is non-inferior to current TB testing. However, if NAAT detects rifampicin resistance, its use may cause the treating health professional to change the anti-tubercular drug regimen. This could have public health benefits by reducing the infectiousness of the patient earlier than the 6–8 weeks required for culture and DST. The use of NAAT in this circumstance is proposed to be superior to current testing approaches.
For patients in whom the pre-test probability of TB is low (i.e. AFB-negative and with indeterminate clinical symptoms), the clinical claim is that NAAT is superior to the current standard testing because a positive NAAT would result in immediate treatment that would not have been indicated based on the low pre-test probability of TB.
In patients suspected of having NTM infections, the applicant proposed that NAAT is expected to provide additional diagnostic information to the tests currently performed to diagnose NTM. The use of NAAT in this population is, therefore, proposed to be superior to the situation where NAAT is not available.
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