TrueNAT MTB Assay Results Interpretation - Indeterminate

“Indeterminate” result on completion of the test run with TrueNAT MTB-Rif Dx means Polymerase Chain Reaction (PCR) melting temperature (Tm) values did not meet the requirements for Rif resistance determination.

Implications

• The initial result of Mycobacterium tuberculosis “DETECTED’ (Truenat MTB) is the bacteriological confirmation of TB.
• TrueNAT MTB Rif Dx did not provide information on resistance to Rif.

Troubleshooting TrueNAT MTB Rif Dx “Indeterminate”

• Test to be repeated using the same DNA eluate or fresh sample.
• Results of the second test:
  • “Rif Resistance Detected” if mutations to Rif are detected
  • “Rif Resistance Not Detected” if mutations to Rif are not detected
  • “Indeterminate”
• If both the results are indeterminate, conduct additional investigations to assess resistance to Rif.

Resources

• Practical Guide to Implementation of Truenat™ Tests for the Detection of TB and Rifampicin Resistance.
• Truenat MTB Rif Pack Insert.

Kindly provide your valuable feedback on the page to the link provided HERE