Diagnostic methods for the detection of Helicobacter pylori infections: a systematic review
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Published:
Oct 15, 2026
Keywords:
Helicobacter pylori, Helicobacter pylori infection, invasive diagnostic methods, non-invasive diagnostic methods, sensitivity, specificity
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Abstract
Introduction. Helicobacter pylori infection is a global public health problem due to its high incidence and associated gastrointestinal diseases. Currently, diagnostic methods are classified as invasive and non-invasive, with varying levels of validity and no consensus on their clinical application. Objective. To compare the diagnostic accuracy of invasive and non-invasive methods for detecting H. pylori infections, based on scientific evidence regarding sensitivity and specificity. Methodology. A systematic review of the evidence was conducted according to the PRISMA 2020 guidelines, focusing on Scopus, PubMed/MEDLINE, and Web of Science, using MeSH controlled terms and descriptors such as: Helicobacter pylori, diagnosis, diagnostic methods, detection, sensitivity, and specificity, combined using Boolean operators. Primary studies on diagnostic accuracy were selected; methodological quality and risk of bias were assessed using QUADAS-2. Results: The comparative analysis showed that invasive methods (histology, biochemical testing for urease activity, and real-time polymerase chain reaction on biopsy specimens) achieved the highest sensitivity and specificity values. Among the non-invasive methods (carbon-13-labeled urea breath test and fecal polymerase chain reaction), validity performance was equivalent to that of invasive methods, establishing them as diagnostic alternatives for H. pylori. Conclusions. The available evidence suggests that invasive methods offer the highest diagnostic accuracy; however, emerging techniques and modalities, along with the implementation of artificial intelligence systems in the diagnosis of H. pylori, are moving toward combined strategies that integrate high-accuracy noninvasive methods. General Area of Study: Clinical laboratory. Specific area of study: Health and Wellness. Type of study: Systematic review.
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Lascano Salazar , K. L., & Ustáriz Fajardo, F. J. (2026). Diagnostic methods for the detection of Helicobacter pylori infections: a systematic review . Anatomía Digital, 9(4), 44-71. https://doi.org/10.33262/anatomiadigital.v9i4.3773
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References
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2. Malfertheiner P, Camargo MC, El-Omar E, Liou JM, Peek R, Schulz C, et al. Helicobacter pylori infection. Nature Reviews Disease Primers [Internet]. 2023 [cited 2026 Sep 7];9(1):19. Available from: http://dx.doi.org/10.1038/s41572-023-00431-8
3. Duan Y, Xu Y, Dou Y, Xu D. Helicobacter pylori and gastric cancer: mechanisms and new perspectives. Journal of Hematology & Oncology [Internet]. 2025 [cited 2026 Sep 7];18(1):10. Available from: http://dx.doi.org/10.1186/s13045-024-01654-2
4. Ali A, AlHussaini KI. Helicobacter pylori: a contemporary perspective on pathogenesis, diagnosis, and treatment strategies. Microorganisms [Internet]. 2024 [cited 2026 Sep 7];12(1):222. Available from: http://dx.doi.org/10.3390/microorganisms12010222
5. Casey O, Dobric M, Kelly O, O'Morain CA. The importance of Helicobacter pylori eradication: a narrative review. Frontiers in Gastroenterology [Internet]. 2026 [cited 2026 Sep 7]; 5:1740221. Available from: http://doi.org/10.3389/fgstr.2026.1740221
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7. Pan American Health Organization. Erradicar la infección por Helicobacter pylori es todo un reto local y mundial [Internet]. OPS; 2021 [citado 2026 Sep 7]. Disponible en: https://www.paho.org/es/noticias/8-3-2021-erradicar-infeccion-por-helicobacter-pylori-es-todo-reto-local-mundial
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9. Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, et al. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut [Internet]. 2022 [cited 2026 Sep 7];71(9):1724-1762. Available from: http://doi.org/10.1136/gutjnl-2022-327745
10. Wang X, Zhang S, Chua EG, He Y, Li X, Liu A, et al. A re-testing range is recommended for ^13C- and ^14C-urea breath tests for Helicobacter pylori infection in China. Gut Pathogens [Internet]. 2021 [cited 2026 Sep 7]; 13:38. Available from: http://doi.org/10.1186/s13099-021-00435-3
11. Mărginean CM, Cioboată R, Olteanu M, Vasile CM, Popescu M, Popescu AIS, et al. The importance of accurate early diagnosis and eradication in Helicobacter pylori infection: pictorial summary review in children and adults. Antibiotics (Basel) [Internet]. 2023 [cited 2026 Sep 7];12(1):60. Available from: http://doi.org/10.3390/antibiotics12010060
12. Horsma-Heikkinen J, Pätäri-Sampo A, Holma T, Nevalainen A, Friberg N, Jarva H, et al. Evaluation of five different methods for diagnosis of Helicobacter pylori from fecal samples. APMIS [Internet]. 2025 [cited 2026 Sep 7];133(1): e13483. Available from: http://doi.org/10.1111/apm.13483
13. Dore MP, Pes GM. What is new in Helicobacter pylori diagnosis? An overview. Journal of Clinical Medicine [Internet]. 2021 [cited 2026 Sep 7]; 10(10):2091. https://doi.org/10.3390/jcm10102091
14. Binmaeil H, Hanafiah A, Mohamed Rose I, Raja Ali RA. Development and validation of multiplex quantitative PCR assay for detection of helicobacter pylori and mutations conferring resistance to clarithromycin and levofloxacin in gastric biopsy. Infect Drug Resist [Internet]. 2021 [cited 2026 Sep 7];14: 4129-4145. Available from: http://doi.org/10.2147/IDR.S325056
15. Pittie G, Laurent T, Radermacher J, Herens S, Boeras A, Ho G. Detection by real-time PCR of helicobacter pylori and clarithromycin resistance compared to histology on gastric biopsies. Microorganisms [Internet]. 2024 [cited 2026 Sep 7];12(11):2192. Available from: http://doi.org/10.3390/microorganisms12112192
16. Ansari S, Yamaoka Y. Helicobacter pylori infection, its laboratory diagnosis, and antimicrobial resistance: a perspective of clinical relevance. Clinical Microbiology Reviews [Internet]. 2022 [cited 2026 Sep 7];35(3): e00258-21. Available from: http://doi.org/10.1128/cmr.00258-21
17. Costa LCMC, das Graças Carvalho M, La Guárdia Custódio Pereira AC, Teixeira Neto RG, Andrade Figueiredo LC, Barros-Pinheiro M. Diagnostic methods for helicobacter pylori. Medical Principles and Practice [Internet]. 2024 [cited 2026 Sep 7];33(3):173-184. Available from: http://doi.org/10.1159/000538349
18. Smith SM, Boyle B, Buckley M, Costigan C, Doyle M, Farrell R, et al. The second Irish Helicobacter pylori Working Group consensus for the diagnosis and treatment of Helicobacter pylori infection in adult patients in Ireland. European journal of gastroenterology & hepatology [Internet]. 2024 [cited 2026 Sep 7];36(8):1000–9. Available from: http://dx.doi.org/10.1097/MEG.0000000000002796
19. Huang H, Li Y, Wu Y, Zhao X, Gao H, Xie X, et al. Advances in Helicobacter pylori detection technology: From pathology-based to multi-omic based methods. TrAC Trends in Analytical Chemistry [Internet]. 2025 [cited 2026 Sep 7];182(118041):118041. Available from: http://dx.doi.org/10.1016/j.trac.2024.118041
20. Ghazanfar H, Javed N, Reina R, Thartori O, Ghazanfar A, Patel H. Advances in diagnostic modalities for helicobacter pylori infection. Life (Basel) [Internet]. 2024 [cited 2026 Sep 7];14(9):1170. Available from: http://dx.doi.org/10.3390/life14091170
21. Jiang Y, Yan H, Cui J, Yang K, An Y. Artificial intelligence in endoscopy for predicting Helicobacter pylori infection: a systematic review and meta-analysis. Helicobacter [Internet]. 2025 [cited 2026 Sep 7];30(2): e70026. Available from: http://doi.org/10.1111/hel.70026
22. Parkash O, Lal A, Subash T, Sultan U, Tahir HN, Hoodbhoy Z, et al. Use of artificial intelligence for the detection of Helicobacter pylori infection from upper gastrointestinal endoscopy images: an updated systematic review and meta-analysis. Annals of Gastroenterology [Internet]. 2024 [cited 2026 Sep 7];37(6):665-673. Available from: http://doi.org/10.20524/aog.2024.0913
23. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ [Internet]. 2021 [cited 2026 Sep 7];372: n71. Available from: http://doi.org/10.1136/bmj.n71
24. Charach L, Perets TT, Gingold-Belfer R, Huta Y, Ashorov O, Levi Z, et al. Comparison of four tests for the diagnosis of Helicobacter pylori infection. Healthcare [Internet]. 2024 [cited 2026 Sep 7];12(15):1479. Available from: http://doi.org/10.3390/healthcare12151479
25. Imperial M, Tan K, Fjell C, Chang Y, Krajden M, Kelly MT, et al. Diagnosis of Helicobacter pylori infection: serology vs. urea breath test. Microbiology Spectrum [Internet]. 2024 [cited 2026 Sep 7];12(11): e01084-24. Available from: http://doi.org/10.1128/spectrum.01084-24
26. Lemos FFB, de Castro CT, Silva Luz M, Rocha GR, Correa Santos GL, de Oliveira Silva LG, et al. Urea breath test for Helicobacter pylori infection in adult dyspeptic patients: a meta-analysis of diagnostic test accuracy. World J Gastroenterol [Internet]. 2024 [cited 2026 Sep 7];30(6):579-598. Available from: http://dx.doi.org/10.3748/wjg.v30.i6.579
27. Ugiagbe RA, Smith SI. Updated review on diagnosis of Helicobacter pylori. Microb Health Dis [Internet]. 2024 [cited 2026 Sep 7];6: e1108. Available from: https://www.microbiotajournal.com/article/1108
28. Fang C, Li P, Jia D, Li Y, Zhang S, Zhang R, et al. Monoclonal stool antigen test for diagnosing Helicobacter pylori in chronic atrophic gastritis: a prospective primary care study. Frontiers in Cellular and Infection Microbiology [Internet]. 2026 [cited 2026 Sep 7]; 16:1811628. Available from: http://doi.org/10.3389/fcimb.2026.1811628
29. Yu KY, Chuang YC, Huang TY, Chou HK, Lu YT, Cherng JH, et al. Evaluation of the Rapid Urease Test (RUT) device for rapid diagnosis of Helicobacter pylori in middle-aged and elderly taiwanese patients. Microorganisms [Internet]. 2025 [cited 2026 Sep 7]; 13:767. Available from: http://dx.doi.org/10.3390/microorganisms13040767
30. Priadko K, Gibaud SA, Druet A, Galmiche L, Megraud F, Corvec S, et al. Real-Time PCR Helicobacter pylori test in comparison with culture and histology for helicobacter pylori detection and identification of resistance to clarithromycin: A Single-Center Real-Life Study. Helicobacter [Internet]. 2025 [cited 2026 Sep 7];30(2): e7003. Available from: http://dx.doi.org/10.1111/hel.70031
31. Kumari R, Kumar M, Seema K, Kumar A, Boipai M, Prasad ML, et al. Diagnostic approaches to Helicobacter pylori: a comparative study of detection in gastric biopsy and aspirates. Cureus [Internet]. 2024 [cited 2026 Sep 7];16(3): e57100. Available from: http://doi.org/10.7759/cureus.57100
32. Yoshikawa T, Yamauchi A, Kou T, Murao T, Kamada T, Suehiro M, et al. Validity of rapid urease test using swab of gastric mucus to mucosal forceps and 13C-urea breath test: a multicenter prospective observational study. BMC Gastroenterology [Internet]. 2024 [cited 2026 Sep 7];24(1):258. Available from: http://doi.org/10.1186/s12876-024-03344-2
33. Resina E, Donday MG, Martínez-Domínguez SJ, Laserna-Mendieta EJ, Lanas Á, Lucendo AJ, et al. Evaluation of a new monoclonal chemiluminescent immunoassay stool antigen test for the diagnosis of helicobacter pylori infection: a spanish multicentre study. Journal of Clinical Medicine [Internet]. 2022 [cited 2026 Sep 7]; 11:5077. Available from: http://doi.org/10.3390/jcm11175077
34. Miftahussurur M, Windia A, Syam AF, Nusi IA, Alfaray RI, Fauzia KA, et al. Diagnostic value of 14C urea breath test for Helicobacter pylori detection compared by histopathology in Indonesian dyspeptic patients. Clinical and Experimental Gastroenterology [Internet]. 2021 [cited 2026 Sep 7]; 14:291-296. Available from: http://dx.doi.org/10.2147/CEG.S306626
35. Pichon M, Pichard B, Barrioz T, Plouzeau C, Croquet V, Fotsing G, et al. Diagnostic accuracy of a noninvasive test for detection of Helicobacter pylori and resistance to clarithromycin in stool by the amplidiag H. pylori ClariR Real-Time PCR Assay. Journal of Clinical Microbiology [Internet]. 2020 [cited 2026 Sep 7];58: e01787-19. Available from: http://dx.doi.org/10.1128/JCM.01787-19
36. Noh CK, Lee GH, Park JW, Roh J, Han JH, Lee E, et al. Diagnostic accuracy of “sweeping” method compared to conventional sampling in rapid urease test for Helicobacter pylori detection in atrophic mucosa. Scientific Reports [Internet]. 2020 [cited 2026 Sep 7];10(1):18483. Available from: http://doi.org/10.1038/s41598-020-75528-1
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