Limitations of TrueNAT MTB Assay

The limitations of TrueNAT Assays are:

• Mycobacterium Tuberculosis (MTB) detection depends on the number of bacilli present in the sample (bacillary load)
• DNA contamination from previous amplifications, positive controls, sample mix-up
• Failure to follow recommended specimen collection, quality, handling and storage
• TB treatment success/ failure cannot be assessed by TrueNAT due to the presence of DNA from dead bacilli
• Mutations within target genes for TrueNAT assays (Polymerase Chain Reaction (PCR) failure)

Above all, any deviation in the process from the procedures described by MolBio Pvt. Ltd. (Goa, India) may alter the assay performance.

Resources

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

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