Truenat MTB and RIF Assay as a TB Diagnostic Test

The tests are performed using Trueprep AUTO Sample Pre-treatment and Prep kits and Truenat micro-PCR chips.

To detect M. tuberculosis, the Truenat MTB chip amplifies a portion of the ribonucleoside-diphosphate reductase gene, nrdB with a Limit of Detection (LOD) of about 100 Colony Forming Units (CFU)/ml sputum sample.

DNA extraction and detection of M. tuberculosis takes approximately one hour.

When M. tuberculosis is detected, as a follow-on test, a small volume of the already extracted DNA is used to test for resistance to Rif using Truenat MTB Rif Dx chip.

Mutations associated with Rif-resistance within the RRDR region of rpoB gene are detected using a probe melt assay and read using the Truelab micro-PCR Analyzer.

The detection of Rif-resistance takes an additional one hour.

Truenat Testing Capacity

• The Truelab Analyzer is available as 1 (Uno), 2 (Duo) or 4 (Quattro) chip ports (figure below).
• The different ports can be used independently to test multiple samples.
• In an eight-hour daily work shift, the estimated throughput of Truelab Analyzer Uno, Duo or Quattro can be 7-9, 15-18, 30-36 specimens, respectively.

Results Reporting 

A Truelab micro PCR printer (figure below) is used to print test results. It can also be connected via SIM card/ Wi-Fi/ Bluetooth to transmit results.

Figure: Different Equipments used in the Truenat Workstation

Resources

• Truenat MTB Pack Insert.
• Truenat MTB Rif Dx Pack Insert.
• Truelab Manual.
• Practical Guide to Implementation of Truenat™ Tests for the Detection of TB and Rifampicin-resistance.

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