Subquestions (for a linked evidence approach): Accuracy What is the accuracy of NAAT in the diagnosis of patients with suspected MTB, compared with AFB microscopy and culture? What is the accuracy of NAAT plus AFB microscopy in the diagnosis of patients with suspected MTB, compared with AFB microscopy alone? What is the accuracy of in-house NAAT compared with commercial NAAT in the diagnosis of patients with suspected MTB, using culture as the reference standard? What is the accuracy of NAAT in the detection of genetic mutations on the rpoB gene that are associated with rifampicin resistance? What is the accuracy of NAAT in the diagnosis of NTM in patients suspected of having an NTM infection, compared with culture? Change in management Does AFB microscopy plus NAAT to determine the presence of MTB and rifampicin resistance change patient management, compared with management decisions made based on AFB microscopy alone, in patients with a high pre-test probability of active TB? Does AFB microscopy plus NAAT to determine the presence of MTB and rifampicin resistance change patient management, compared with management decisions made based on AFB microscopy alone, in patients with a low-pre-test probability of TB? Does NAAT plus culture change patient management, compared with culture plus other tests, in patients suspected of having an NTM infection? Effectiveness of change in management To what extent does treating patients who have rifampicin-resistant MTB infections with alternative treatments result in better health outcomes for the patient and their contacts? What is the health impact of early versus delayed treatment of TB on the individual and their contacts? What adverse events (AEs) are associated with inappropriate antibiotic treatment for TB? Diagnostic assessment framework This assessment uses the theoretical framework outlined in the MSAC Guidelines for the assessment of diagnostic technologies (). This means that evidence of the clinical effectiveness of diagnosing MTB or NTB using NAAT requires either:
Subquestions (for a linked evidence approach): Accuracy What is the accuracy of NAAT in the diagnosis of patients with suspected MTB, compared with AFB microscopy and culture? What is the accuracy of NAAT plus AFB microscopy in the diagnosis of patients with suspected MTB, compared with AFB microscopy alone? What is the accuracy of in-house NAAT compared with commercial NAAT in the diagnosis of patients with suspected MTB, using culture as the reference standard? What is the accuracy of NAAT in the detection of genetic mutations on the rpoB gene that are associated with rifampicin resistance? What is the accuracy of NAAT in the diagnosis of NTM in patients suspected of having an NTM infection, compared with culture? Change in management Does AFB microscopy plus NAAT to determine the presence of MTB and rifampicin resistance change patient management, compared with management decisions made based on AFB microscopy alone, in patients with a high pre-test probability of active TB? Does AFB microscopy plus NAAT to determine the presence of MTB and rifampicin resistance change patient management, compared with management decisions made based on AFB microscopy alone, in patients with a low-pre-test probability of TB? Does NAAT plus culture change patient management, compared with culture plus other tests, in patients suspected of having an NTM infection? Effectiveness of change in management To what extent does treating patients who have rifampicin-resistant MTB infections with alternative treatments result in better health outcomes for the patient and their contacts? What is the health impact of early versus delayed treatment of TB on the individual and their contacts? What adverse events (AEs) are associated with inappropriate antibiotic treatment for TB? Diagnostic assessment framework This assessment uses the theoretical framework outlined in the MSAC Guidelines for the assessment of diagnostic technologies (). This means that evidence of the clinical effectiveness of diagnosing MTB or NTB using NAAT requires either:
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