Evaluation of the Truenat® chip-based real-time PCR platform for infectious disease diagnostics.

OBJECTIVE

This study aimed to evaluate the Trueprep/Truelab platform with four Truenat assays (COVID-19, Mycobacterium tuberculosis - MTB, malaria, leptospirosis), focusing on analytical performance, repeat rates, and time-to-result.

METHODS

Remnant clinical specimens and commercial controls were analyzed under routine conditions. Performance metrics included accuracy, reproducibility, limit of detection (LOD), linearity, and specificity, when applicable. Each analyte was tested in replicates, and results were compared with established reference methods.

RESULTS

The Truenat COVID-19 assay achieved 100% agreement with the reference and LOD of 500 copies/mL. Truenat MTB showed 95% concordance with the comparator, though repeat runs were occasionally required (7.3%). Malaria assays demonstrated high reproducibility and linearity (R2 = 0.9996) with an observed LOD of 3000 copies/mL. Leptospira assays yielded 100% accuracy with a LOD of 750 copies/mL. Performance generally matched manufacturer specifications, though low-burden MTB samples were less consistently detected.

CONCLUSION

Truenat assays showed reliable analytical performance, especially for COVID-19. While MTB detection remains more robust with Xpert Ultra in low-burden cases, Truenat provides a viable point-of-care alternative in resource-limited settings. For malaria and leptospirosis, broader clinical validation is needed before routine implementation in our service.