An assessment of nucleic acid amplification testing for active mycobacterial infection



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tarix04.01.2022
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Intended purpose


NAAT is intended for use with specimens from untreated patients (i.e. < 3 days of anti-TB drug treatment) for whom there is a clinical suspicion of TB. As the number of bacilli reduces rapidly within days to 2 weeks after commencing appropriate TB treatment (providing the MTB is not drug resistant), MTB cannot be reliably detected in treated patients.

The applicant recommended that NAAT should only be performed in institutions proficient in the culture and identification of MTB. Transport and storage at 2–8 °C is important for this test, and samples should preferably be read within 24–48 hours (prolonged storage > 4 days has been reported to impact on results). Results can be provided to clinicians within 24–48 hours.

There are recognised guidelines for Australian mycobacteriology laboratories that specify the biosafety procedures, infrastructure, equipment and work practices required by the laboratory (National Tuberculosis Advisory Committee 2006). Laboratories performing TB cultures must participate in a recognised quality assurance program.


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