Sharma K, Jindal N, Sharma M, Mandavdhare HS, Gupta P, Sekar A, Dutta U, Sharma V. Xpert Ultra and TrueNat MTB plus assays for the diagnosis of gastrointestinal tuberculosis: A diagnostic accuracy study. World J Gastroenterol 2026; 32(14): 116088 [DOI: 10.3748/wjg.v32.i14.116088]
Corresponding Author of This Article
Vishal Sharma, MD, Department of Gastroenterology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh 160012, India. sharma.vishal@pgimer.edu.in
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Observational Study
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This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Apr 14, 2026 (publication date) through Apr 3, 2026
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Journal Information of This Article
Publication Name
World Journal of Gastroenterology
ISSN
1007-9327
Publisher of This Article
Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
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Sharma K, Jindal N, Sharma M, Mandavdhare HS, Gupta P, Sekar A, Dutta U, Sharma V. Xpert Ultra and TrueNat MTB plus assays for the diagnosis of gastrointestinal tuberculosis: A diagnostic accuracy study. World J Gastroenterol 2026; 32(14): 116088 [DOI: 10.3748/wjg.v32.i14.116088]
Kusum Sharma, Megha Sharma, Department of Microbiology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India
Neha Jindal, Harshal S Mandavdhare, Usha Dutta, Vishal Sharma, Department of Gastroenterology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India
Pankaj Gupta, Department of Radiodiagnosis and Imaging, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India
Aravind Sekar, Department of Histopathology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India
Author contributions: Sharma K and Sharma V contributed to study design and conceptualization; Sharma K, Jindal N, and Sharma V participated in data collection and analysis, Sharma K, Sharma M, and Gupta P performed the laboratory work and interpretation; Jindal N, Mandavdhare HS, Dutta U, and Sharma V participated in patient recruitment and follow-up; Jindal N, Sharma K, and Sharma V wrote the initial draft; Sharma M, Mandavdhare HS, Gupta P, and Dutta U edited the manuscript. All authors have read and approved the final manuscript.
Institutional review board statement: The study was approved by the Ethics Committee of Postgraduate Institute of Medical Education and Research, No. PGI/IEC/2021/000646.
Informed consent statement: All participants provided written informed consent before inclusion in this study.
Conflict-of-interest statement: The authors report no relevant conflicts of interest for this article.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Data sharing statement: Data associated with this manuscript are available from the corresponding author upon reasonable request.
Corresponding author: Vishal Sharma, MD, Department of Gastroenterology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh 160012, India. sharma.vishal@pgimer.edu.in
Received: November 2, 2025 Revised: December 30, 2025 Accepted: February 2, 2026 Published online: April 14, 2026 Processing time: 152 Days and 12.7 Hours
Abstract
BACKGROUND
Discriminating between gastrointestinal tuberculosis (GITB) and Crohn’s disease is a perplexing challenge for clinicians. The clinical presentation, endoscopic appearances, radiographic features, and histological findings of these two granulomatous disorders are similar.
AIM
To study the diagnostic accuracy of Xpert MTB/RIF Ultra (Xpert Ultra) and TrueNat MTB plus assay (TrueNat Plus) in the diagnosis of GITB diagnosis.
METHODS
We prospectively included patients suspected to have GITB who underwent colonoscopy and had endoscopic findings consistent with tuberculosis, such as ulcers, ulcerated strictures, and ulcero-polypoidal lesions. Xpert Ultra and TrueNat Plus assays were performed using standard protocols from intestinal tissue to assess the comparative performance of the two assays (Xpert Ultra and TrueNAT Plus) in diagnosing GITB compared with a composite reference standard (CRS). The CRS included a combination of clinical symptoms, tissue acid-fast bacilli smear/culture, imaging findings, histopathology, and response to therapy to diagnose GITB.
RESULTS
Of the 38 patients with complete follow-up, 26 had GITB, and 12 served as controls (n = 10 Crohn’s disease cases, n = 2 alternate diagnosis). GITB cases included three acid-fast bacilli culture-positive patients, four with granulomas, 17 with Xpert Ultra positivity and 15 with TrueNat plus positivity. Compared with the CRS, the overall sensitivity and specificity of Xpert Ultra for the diagnosis of GITB was 65.38% [95% confidence interval (CI): 44.33-82.79] and 83.33% (95%CI: 51.59-97.91), respectively. TrueNat plus had a sensitivity of 57.69% (95%CI: 36.92-76.65) and specificity of 50% (95%CI: 21.09-78.91).
CONCLUSION
TrueNat plus has a lower sensitivity and specificity compared with Xpert Ultra. However, the improved sensitivity of these tests compared with standard tests comes at the cost of reduced specificity.
Core Tip: This study compared Xpert Ultra and TrueNat plus assays for diagnosing gastrointestinal tuberculosis against a composite reference standard. Of 38 patients, 26 had gastrointestinal tuberculosis. Xpert Ultra showed higher sensitivity and specificity than TrueNat plus in intestinal tissue samples. The improved sensitivity of these tests compared with standard tests comes at the cost of reduced specificity.
