Specific Performance Characteristics of TrueNAT: Analytical Exclusivity [Primer Specificity]

TrueNAT assays are Polymerase Chain Reaction (PCR) tests performed using freeze dried PCR reagents and primers contained in microtubes mixed with eluted DNA (Trueprep device) and amplified on Truelab device.

The primers for PCR are designed to amplify ribonucleoside-diphosphate reductase gene - nrdZ gene in Mycobacterium tuberculosis (MTB) genome.

Analytical Exclusivity (Primer Specificity) test were done by the manufacturer to determine the specificity of the TrueNAT Assays by:

• Amplification of genetic material (DNA/RNA) from different microorganisms (Figure 1). Results showed no cross-reactivity of TrueNAT MTB Assay with tested microorganisms.
• Amplification of genetic material from Non-tuberculosis mycobacterium (NTM) strains (Figure 2). Results showed no cross reactivity in performance of TrueNAT MTB Assay.

Figure 1: Microorganisms tested to check Analytical Exclusivity of TrueNAT MTB Assay Primers; Source: Truenat MTB Pack Insert

Figure 2: Non-tuberculosis mycobacterium (NTM) tested to check Analytical Exclusivity of TrueNAT MTB Assay Primers; Source: Truenat MTB Pack Insert

Resources

• Truenat MTB Pack Insert.

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