ArticleJournal of clinical microbiology2021
Diagnosing Pulmonary Tuberculosis by Using Sequence-Specific Purification of Urine Cell-Free DNA.
Article in Journal of clinical microbiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- Urine-based diagnostic tests for tuberculosis: a scoping review highlighting unmet diagnostic needs.Frontiers in microbiology · 2026Pooled it
- Diagnostic accuracy of Mycobacterium tuberculosis cell-free DNA for tuberculosis: A systematic review and meta-analysis.PloS one · 2021Pooled it
- AI Based Cough Analysis for Pulmonary Tuberculosis Triage and Diagnosis: A Technical Review.npj biomedical innovations · 2026Review
- Detection of Mycobacterium tuberculosis antigens in urinary extracellular vesicles using real-time immuno-PCR: A non-invasive diagnostic approach for pulmonary tuberculosis.Scientific reports · 2026Article
- Expanding role of cell-free DNA for the early diagnosis and monitoring of pulmonary diseases.Chinese medical journal · 2026Review
- Role of cell-free DNA technology in assisting paraffin-embedded cytology for the pathological diagnosis of pulmonary tuberculosis.BMC pulmonary medicine · 2026Article
- Automated Enrichment of DNA Biomarkers from Large-Volume Samples: Detection ofAnalytical chemistry · 2026Article
- Impact of preanalytical variables on urinary cell-free DNA quality: Centrifugation, EDTA concentration, storage and thawing strategies.PloS one · 2026Article
- A low-cost point-of-care device for the simultaneous detection of two sexually transmitted bacterial pathogens in vaginal swab samples.The Analyst · 2025Article
- High-sensitivity detection ofJournal of clinical microbiology · 2025Article
- Article
- Detection of Mycobacterium tuberculosis transrenal DNA in urine samples among adults in Peru.Tuberculosis (Edinburgh, Scotland) · 2024Article
- High-sensitivity detection ofmedRxiv : the preprint server for health sciences · 2024Article
- Diagnostic accuracy of a sequence-specificMicrobiology spectrum · 2024Article
- Diagnostic accuracy of tongue swab testing on two automated tuberculosis diagnostic platforms, Cepheid Xpert MTB/RIF Ultra and Molbio Truenat MTB Ultima.Journal of clinical microbiology · 2024Article
- Detection of Mycobacterium tuberculosis from tongue swabs using sonication and sequence-specific hybridization capture.PloS one · 2024Article
- The impact of preanalytical variables on the analysis of cell-free DNA from blood and urine samples.Frontiers in cell and developmental biology · 2024Review
- Tongue swab testing on two automated tuberculosis diagnostic platforms, Cepheid XpertmedRxiv : the preprint server for health sciences · 2023Article
- Advanced HIV disease: A review of diagnostic and prophylactic strategies.HIV medicine · 2023Review
- Innovative laboratory methods for improved tuberculosis diagnosis and drug-susceptibility testing.Frontiers in tuberculosis · 2023Review
Corrections and comments
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Authors and funding
12 authors at 4 institutions in 3 countries.
Funding
Abstract
Transrenal urine cell-free DNA (cfDNA) is a promising tuberculosis (TB) biomarker, but is challenging to detect because of the short length (<100 bp) and low concentration of TB-specific fragments. We aimed to improve the diagnostic sensitivity of TB urine cfDNA by increasing recovery of short fragments during sample preparation. We developed a highly sensitive sequence-specific purification method that uses hybridization probes immobilized on magnetic beads to capture short TB cfDNA (50 bp) with 91.8% average efficiency. Combined with short-target PCR, the assay limit of detection was ≤5 copies of cfDNA in 10 ml urine. In a clinical cohort study in South Africa, our urine cfDNA assay had 83.7% sensitivity (95% CI: 71.0 to 91.5%) and 100% specificity (95% CI: 86.2 to 100%) for diagnosis of active pulmonary TB when using sputum Xpert MTB/RIF as the reference standard. The detected cfDNA concentration was 0.14 to 2,804 copies/ml (median 14.6 copies/ml) and was inversely correlated with CD4 count and days to culture positivity. Sensitivity was nonsignificantly higher in HIV-positive (88.2%) compared to HIV-negative patients (73.3%), and was not dependent on CD4 count. Sensitivity remained high in sputum smear-negative (76.0%) and urine lipoarabinomannan (LAM)-negative (76.5%) patients. With improved sample preparation, urine cfDNA is a viable biomarker for TB diagnosis. Our assay has the highest reported accuracy of any TB urine cfDNA test to date and has the potential to enable rapid non-sputum-based TB diagnosis across key underserved patient populations.
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Registered trials
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