ArticleBMC infectious diseases2024
Performance evaluation of Truenat MTB and Truenat MTB-RIF DX assays in comparison to gene XPERT MTB/RIF ultra for the diagnosis of pulmonary tuberculosis in Uganda.
Article in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.
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Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Implementation determinants of rapid diagnostic tests for fever management in sub-Saharan Africa: a mixed-studies systematic review.Nature communications · 2026Pooled it
- Xpert MTB/RIF Ultra assay for pulmonary tuberculosis and rifampicin resistance in adults and adolescents.The Cochrane database of systematic reviews · 2025Pooled it
- Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents.The Cochrane database of systematic reviews · 2025Pooled it
- Current Landscape of Molecular Diagnostic Tests and Emerging Tools for Tuberculosis and Drug Resistance.Diagnostics (Basel, Switzerland) · 2026Review
- Evaluation of the Truenat® chip-based real-time PCR platform for infectious disease diagnostics.Practical laboratory medicine · 2026Article
- Evaluation of the Novel RITA MTBC Assay for Tuberculosis Detection: A Pilot Comparison with GeneXpert and BD MAX™.Pathogens (Basel, Switzerland) · 2025Article
- Genetic Characterization of Mycobacterium Tuberculosis Isolated from Captive Zoo Animals.EcoHealth · 2025Article
- Multicentric validation of the PathoDetect™ MTB RIF & INH assay for simultaneous detection of Mycobacterium tuberculosis, & drug resistance to rifampicin & isoniazid in presumptive pulmonary tuberculosis & drug-resistant TB patients.The Indian journal of medical research · 2025Article
- Accuracy of Truenat™ MTB Plus for the diagnosis of pulmonary TB.IJTLD open · 2025Article
- A Comprehensive Review of the Diagnostics for Pediatric Tuberculosis Based on Assay Time, Ease of Operation, and Performance.Microorganisms · 2025Review
- Efficacy of Xpert MTB/RIF assay in detecting Mycobacterium tuberculosis in samples with different results by smear and culture in a coastal city with high incidence of tuberculosis.BMC infectious diseases · 2025Article
- Diagnostic accuracy of the TrueNat™ MTB plus assay for detecting pulmonary tuberculosis in adults.PloS one · 2025Article
- Quantum Dot-Based Nanosensors for In Vitro Detection ofNanomaterials (Basel, Switzerland) · 2024Review
- ISCCM Position Statement on the Approach to and Management of Critically Ill Patients with Tuberculosis.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2024Article
- Tuberculosis diagnosis versus GeneXpertBioanalysis · 2024Article
- Diagnostic accuracy of the novel and biosafe molecular assay Orange G3 TBC compared to GeneXpert for tuberculosis diagnosis in resource-limited settings.Therapeutic advances in infectious diseaseArticle
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8 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundThe World Health Organization endorsed Truenat MTB rapid molecular assay in 2020 and recommended additional in-country evaluation studies before uptake. We evaluated the accuracy and operational feasibility of Truenat MTB assay (Truenat) in comparison with GeneXpert Ultra and culture.
methodsIn a cross-sectional study of 250 presumptive TB patients, participants were requested to provide a sputum sample on the day of their visit to the clinic. The sputum sample was homogenized and a portion was tested using GeneXpert Ultra as per the routine standard procedure and the other portion was tested using Truenat assay at the clinic laboratory. The second sample portion was processed for Concentrated Fluorescent smear Microscopy (CFM), LJ, and MGIT cultures. Truenat sensitivity and specificity were compared to GeneXpert Ultra and culture. Test performance characteristics and operational feasibility assessment data through interview of the study laboratory staff were also collected and summarized as proportions and percentages.
resultsOf the 250 participants recruited in the study, the sensitivity and specificity of Truenat was n/N (%, 95%CI); 66/82 (80.5, 70.2-88.4) and 156/159 (98.1, 94.5-99.6) when compared with Ultra, 50/64 (89.3, 66.0-87.4) and 166/180 (92.2, 87.2-95.6) when compared with LJ, 58/71 (81.7,70.7-89.8) and 131/138 (94.9, 89.8-97.9) when compared to MGIT culture and 59/73 (80.8, 69.9-89.1) and 159/169 (94.1,89.3-97.1) when compared to LJ and/or MGIT culture. The sensitivity of Truenat was lower, 14/23 (60.9, 40.6-82.8) among smear-negative compared to 45/50 (90.0, 78.1-96.6) among smear-positive participants but not different by HIV status. There were no special training needs especially among laboratory personnel with previous GeneXpert /molecular test experience, 19/242 (7.8%) error/invalid, and 12 (17,4%) uninterpretable/indeterminate results mainly for rifampicin resistance determination. However, there were 3 (3.5%) of GeneXpert Ultra indeterminate results.
conclusionAmong presumptive TB patients in Uganda, the Truenat assay has high sensitivity and specificity. The Truenat assay has acceptable operational feasibility attributes when compared with the GeneXpert Assay.
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