Evidence map›Paper›PMID 39906319›Full record

ArticleOpen forum infectious diseases2025

Programmatic Diagnostic Accuracy and Clinical Utility of Xpert MTB/XDR in Patients With Rifampicin-Resistant Tuberculosis in Georgia.

Theresa Pfurtscheller, Ana Tsutsunava, Nino Maghradze, Mariam Gujabidze, Nino Bablishvili, Seda Yerlikaya, Claudia M Denkinger, Nestani Tukvadze, Ankur Gupta-Wright

Abstract read
In one paragraph

Article in Open forum infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Theresa PfurtschellerDepartment of Infectious Diseases and Tropical Medicine, University Hospital Heidelberg, Heidelberg, Germany.ORCID https://orcid.org/0000-0002-0549-9790
Ana TsutsunavaScientific Department, National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia.
Nino MaghradzeScientific Department, National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia.ORCID https://orcid.org/0000-0003-1227-1900
Mariam GujabidzeScientific Department, National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia.
Nino BablishviliScientific Department, National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia.
Seda YerlikayaDepartment of Infectious Diseases and Tropical Medicine, University Hospital Heidelberg, Heidelberg, Germany.ORCID https://orcid.org/0000-0002-6064-548X
Claudia M DenkingerDepartment of Infectious Diseases and Tropical Medicine, University Hospital Heidelberg, Heidelberg, Germany.ORCID https://orcid.org/0000-0002-7216-7067
Nestani TukvadzeScientific Department, National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia.
Ankur Gupta-WrightDepartment of Infectious Diseases and Tropical Medicine, University Hospital Heidelberg, Heidelberg, Germany.ORCID https://orcid.org/0000-0002-5150-2970

Funding

Rapid Research for Diagnostics Development in TB Network (R2D2 TB Network)U01AI152087 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CATTAMANCHI, ADITHYA, DENKINGER, CLAUDIA MARIA · 2020 to 2024
$19.3M
Emory-Georgia TB Research Training ProgramD43TW007124 · FIC · EMORY UNIVERSITY · PI HENRY M BLUMBERG, Nestani Tukvadze · 2004 to 2026
$4.6M
FIC NIH HHS D43 TW007124NIAID NIH HHS U01 AI152087
6 · The paper itself

Abstract

Background: Xpert MTB/XDR (Cepheid) is recommended by the World Health Organization for drug susceptibility testing in patients with tuberculosis, with potential for rapid detection of isoniazid and fluoroquinolone resistance. However, diagnostic accuracy and clinical utility in a programmatic setting are unknown. Methods: We evaluated the accuracy and clinical utility of Xpert MTB/XDR in patients with rifampicin-resistant pulmonary tuberculosis during programmatic implementation in Georgia between July 2022 and August 2024, using phenotypic drug susceptibility testing (DST) as a reference standard. Results: An overall 140 patients were tested with Xpert MTB/XDR and phenotypic DST, and 94.9% and 33.8% had isoniazid and fluoroquinolone resistance by phenotypic DST, respectively. Xpert MTB/XDR showed 99.2% sensitivity (95% CI, 95.5%-100%) and 100% specificity (95% CI, 54.1%-100%) for isoniazid resistance. Sensitivity and specificity for fluoroquinolone resistance were 88.4% (95% CI, 74.9%-96.1%) and 100% (95% CI, 95.6%-100%). When indeterminate/invalid Xpert MTB/XDR results were included, 17.4% (8/46) and 6.2% (8/129) of patients with phenotypic fluoroquinolone and isoniazid resistance were missed. Median turnaround time for Xpert MTB/XDR was 1 day (IQR, 1-3) and median time to treatment was 4 days (IQR, 1-7). Phenotypic DST results took a median 43 days (IQR, 29-63) longer than Xpert MTB/XDR results. Finally, 95% (115/121; 95% CI, 89.5%-98.2%) of patients had fluoroquinolones appropriately prescribed based on Xpert MTB/XDR results. Conclusions: Programmatic data confirm the high accuracy of Xpert MTB/XDR, despite being below the World Health Organization target product profile targets for fluoroquinolones, with significantly faster time to results than phenotypic DST.

Identifiers

PMID39906319
PMCPMC11793029

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.