Evidence map›Paper›PMID 39233548›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

Prospective Exploratory Evaluation of Cepheid Xpert Mycobacterium tuberculosis Host Response Cartridge: A Focus on Adolescents and Young Adults.

Marva Seifert, Donald G Catanzaro, Michael Gracia, Naomi Hillery, Sabira Tahseen, Faisal Masood, Alamdar Hussain, Uzma Majeed, Rebecca E Colman, Rehan R Syed and 2 more

Abstract readEvaluation Study
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
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  5. Review
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

12 authors.

Marva SeifertDivision of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, USA.ORCID 0000-0002-7554-6396
Donald G CatanzaroDepartment of Biological Sciences, University of Arkansas, Fayetteville, USA.ORCID 0000-0003-1760-0574
Michael GraciaDepartment of Pediatrics, University of California San Diego, La Jolla, USA.
Naomi HilleryDivision of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, USA.
Sabira TahseenNational Tuberculosis Control Program, National Tuberculosis Reference Laboratory, Islamabad, Pakistan.
Faisal MasoodNational Tuberculosis Control Program, National Tuberculosis Reference Laboratory, Islamabad, Pakistan.
Alamdar HussainNational Tuberculosis Control Program, National Tuberculosis Reference Laboratory, Islamabad, Pakistan.
Uzma MajeedNational Tuberculosis Control Program, National Tuberculosis Reference Laboratory, Islamabad, Pakistan.
Rebecca E ColmanDivision of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, USA.
Rehan R SyedDivision of Infectious Diseases and Global Public Health, Department of Medicine, University of California, San Diego, La Jolla, USA.
Antonino CatanzaroDivision of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, USA.
Timothy RodwellDivision of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, USA.

Funding

VirologyP30AI036214 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SUSAN JANET LITTLE · 1994 to 2026
$78.4M
HOPE Training GrantT32AI007384 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Sara Gianella Weibel, Scott L Letendre · 1990 to 2026
$9.7M
Identifying individuals at risk of progression to active tuberculosisR01AI137681 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CATANZARO, ANTONINO, RODWELL, TIMOTHY CHARLES · 2018 to 2022
$3.7M
MTBNIAID NIH HHS P30 AI036214NIAID NIH HHS R01 AI137681NIAID NIH HHS T32 AI007384NIH HHS T32AI007384
6 · The paper itself

Abstract

backgroundAn accurate, rapid, non-sputum-based triage test for diagnosing tuberculosis (TB) is needed.

methodsA prospective evaluation of the Cepheid GeneXpert Mycobacterium tuberculosis Host Response cartridge (Xpert-MTB-HR), a prototype blood-based host response mRNA signature assay, among individuals presenting with TB-like symptoms was performed in Pakistan and results were compared to 3 reference standards: Xpert MTB/RIF Ultra, bacteriological confirmation (Xpert MTB/RIF Ultra and/or culture positivity), and composite clinical diagnosis (clinician diagnosis, treatment initiation, Xpert MTB/RIF Ultra, and/or culture positivity). Analyses were conducted both for the entire study cohort and separately in the adolescent and young adult cohort (aged 10-24 years).

resultsA total of 497 participants, aged 6-83 years, returned valid Xpert-MTB-HR results. When a diagnostic threshold was set for a sensitivity of >90%, specificity was 32% (95% confidence interval [CI], 28%-37%) compared to Xpert MTB/RIF Ultra, 29% (95% CI, 25%-34%) compared to a bacteriological confirmation, and 22% (95% CI, 18%-26%) compared to a composite clinical diagnosis. However, when evaluating only the adolescent and young adult cohort with a diagnostic threshold set for sensitivity of >90%, specificity was 82% (95% CI, 74%-89%) compared to Xpert MTB/RIF Ultra, 84% (95% CI, 75%-90%) compared to a bacteriological confirmation, and 54% (95% CI, 44%-64%) compared to a composite clinical diagnosis.

conclusionsWhile the Xpert-MTB-HR does not meet World Health Organization minimum criteria in the general population, in our study it does meet the minimum sensitivity and specificity requirements for a non-sputum-based triage test among adolescents and young adults when compared to Xpert MTB/RIF Ultra or bacteriological confirmation.

Indexed as

Molecular Diagnostic TechniquesMycobacterium tuberculosisTuberculosisAdolescentAdultAgedChildFemaleHumansMaleMiddle AgedPakistanProspective StudiesSensitivity and SpecificityYoung Adultadolescents and young adultsCepheid GeneXpert-MTB-HR Cartridgediagnostichost responseMycobacterium tuberculosis

Identifiers

PMID39233548
PMCPMC11797382

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.