Validation of the loop-mediated isothermal amplification compared with real-time micro-PCR and conventional methods for the detection of pulmonary tuberculosis
Year: 2026
Type: article
Study design: Observational Study
Abstract: Background: Efficient diagnosis and proper identification of Mycobacterium tuberculosis (MTB) are still a crucial point in control of tuberculosis (TB), especially in resource-poor regions. The aim of this study was to determine the diagnostic concordance accuracy of a colorimetric Loop-Mediated Isothermal Amplification (TB-LAMP) assay against microscopy, real-time micro-PCR assay and Middlebrook 7H9 broth culture.Materials and Methods: In the World Health Organization (WHO) inclusion criteria, 270 clinically suspected pulmonary TB patients' sputum samples were obtained. Direct and concentrated smear microscopy, TB-LAMP and TrueNat for MTB were performed on the samples with Middlebrook 7H9 broth culture (gold standard). McNemar’s and Friedman tests were used for statistical analysis of sensitivity, specificity and concordance.Results: Among 270 samples, 112 (41.48%) were culture-positive. Conventional smear microscopy was a modest diagnostic sensitivity of 70.43% that rose to 79.31%, when the sample was concentrated. Molecular assays, such as LAMP (89.66%) and TrueNat (93.97%), on the other hand, presented significantly higher sensitivity, demonstrating their improved analytical performance and decreased risk for false-negative results. Specificity was also substantially enhanced, and it was 98.7% (95% CI: 95.39-99.84) with the TrueNat assay. The reference standard test, culture for M. tuberculosis, unsurprisingly was 100% accuracy of diagnosis.Conclusion: The colorimetric TB-LAMP assay provides a rapid, sensitive, and highly specific alternative to conventional diagnostics for MTB detection.
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7166345607