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  4. Diagnostic accuracy of a sequence-specific Mtb-DNA hybridization assay in urine: a case-control study including subclinical TB cases
 
research article

Diagnostic accuracy of a sequence-specific Mtb-DNA hybridization assay in urine: a case-control study including subclinical TB cases

Tschan, Yves
•
Sasamalo, Mohamed
•
Hiza, Hellen
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May 8, 2024
Microbiology Spectrum

Tuberculosis (TB) caused by Mycobacterium tuberculosis (Mtb) remains one of the deadliest infectious diseases globally. Timely diagnosis is a key step in the management of TB patients and in the prevention of further transmission events. Current diagnostic tools are limited in these regards. There is an urgent need for new accurate non-sputum-based diagnostic tools for the detection of symptomatic as well as subclinical TB. In this study, we recruited 52 symptomatic TB patients (sputum Xpert MTB/RIF positive) and 58 household contacts to assess the accuracy of a sequence-specific hybridization assay that detects the presence of Mtb cell-free DNA in urine. Using sputum Xpert MTB/RIF as a reference test, the magnetic bead-capture assay could discriminate active TB from healthy household contacts with an overall sensitivity of 72.1% [confidence interval (CI) 0.59-0.86] and specificity of 95.5% (CI 0.90-1.02) with a positive predictive value of 93.9% and negative predictive value of 78.2%. The detection of Mtb-specific DNA in urine suggested four asymptomatic TB infection cases that were confirmed in all instances either by concomitant Xpert MTB/RIF sputum testing or by follow-up investigation raising the specificity of the index test to 100%. We conclude that sequence-specific hybridization assays on urine specimens hold promise as non-invasive tests for the detection of subclinical TB.

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Type
research article
DOI
10.1128/spectrum.00426-24
Web of Science ID

WOS:001215847300001

Author(s)
Tschan, Yves
Sasamalo, Mohamed
Hiza, Hellen
Fellay, Jacques  
Gagneux, Sebastien
Reither, Klaus
Hella, Jerry
Portevin, Damien
Date Issued

2024-05-08

Publisher

Washington

Published in
Microbiology Spectrum
Subjects

Life Sciences & Biomedicine

•

Tuberculosis

•

Diagnosis

•

Non-Sputum

•

Urine

•

Cell-Free Dna

Editorial or Peer reviewed

REVIEWED

Written at

EPFL

EPFL units
UPFELLAY  
FunderGrant Number

Swiss National Science Foundation (SNSF)

Available on Infoscience
May 16, 2024
Use this identifier to reference this record
https://infoscience.epfl.ch/handle/20.500.14299/208023
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