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Diagnostic Value of the Pylori DuoTect Test for Helicobacter pylori Detection in the Vietnamese Population.

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Title: Diagnostic Value of the Pylori DuoTect Test for Helicobacter pylori Detection in the Vietnamese Population.
Authors: Viet HD; Internal Medicine Faculty, Hanoi Medical University, Hanoi, Vietnam.; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.; Endoscopy Centre, Hanoi Medical University Hospital, Hanoi, Vietnam., Phuc BN; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam., Thi TD; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam., Huyen TNT; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam., Thu TN; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam., Thu UVT; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam., Bao LH; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.; College of Health Sciences, VinUniversity, Hanoi, Vietnam., Van LD; Internal Medicine Faculty, Hanoi Medical University, Hanoi, Vietnam.; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.; Endoscopy Centre, Hanoi Medical University Hospital, Hanoi, Vietnam.
Source: Helicobacter [Helicobacter] 2026 Jul-Aug; Vol. 31 (4), pp. e70155.
Publication Type: Journal Article; Evaluation Study
Language: English
Journal Info: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 9605411 Publication Model: Print Cited Medium: Internet ISSN: 1523-5378 (Electronic) Linking ISSN: 10834389 NLM ISO Abbreviation: Helicobacter Subsets: MEDLINE
Imprint Name(s): Publication: Oxford : Wiley-Blackwell
Original Publication: Malden, MA : Wiley-Blackwell, c1996-
MeSH Terms: Helicobacter Infections*/diagnosis , Helicobacter Infections*/microbiology , Helicobacter pylori*/isolation & purification , Helicobacter pylori*/immunology , Antibodies, Bacterial*/blood, Vietnam/epidemiology ; Antigens, Bacterial/immunology ; Bacterial Proteins/immunology ; Urease/analysis ; Humans ; Female ; Cross-Sectional Studies ; Middle Aged ; Male ; Adult ; Sensitivity and Specificity ; Breath Tests ; Aged
Abstract: Objectives: To evaluate the diagnostic accuracy in Helicobacter pylori detection using blood test with FliD and CagA antibodies (Pylori DuoTect), comparing with rapid urease test (RUT) and urease breath test (UBT) in Vietnamese patients with upper GI symptoms.
Methods: A cross-sectional study was conducted at the Institute of Gastroenterology and Hepatology in Hanoi, Vietnam on adults with upper GI symptoms, no prior treatment of peptic ulcers, and no history of H. pylori infection. Participants underwent upper GI endoscopy and three H. pylori tests, including rapid urease test (RUT), urea breath test (UBT), and Pylori DuoTect. Pylori DuoTect was considered positive if either FliD or CagA antibodies were detected. The H. pylori infection was defined as both RUT and UBT positive. Endoscopic findings were classified using the Kyoto classification score for gastritis. Diagnostic accuracy was evaluated using sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Results: From December 1, 2023, to August 9, 2024, 333 patients were recruited (mean age 45.9 years, 39.9% male). The most common symptom was epigastric pain (49.5%). The prevalences of gastritis, gastric ulcers, and duodenal ulcers were 92.7%, 12.1%, and 8.1%, respectively. Pylori DuoTect was positive in 51.9% of patients (FliD: 34.8% and CagA: 66.6%). Using the gold standard, 33.6% were diagnosed with H. pylori infection. The sensitivity, specificity, PPV, and NPV of Pylori DuoTect were 83.0%, 64.0%, 54.0%, and 88.0%, respectively. Combining Pylori DuoTect and endoscopy findings (peptic ulcer or Kyoto score ≥ 2) improved the sensitivity from 0.83 to 0.88 and increased NPV.
Conclusion: Pylori DuoTect had moderate sensitivity and low specificity in the diagnosis of H. pylori infection in Vietnamese adult patients.
(© 2026 John Wiley & Sons Ltd.)
References: Clin Gastroenterol Hepatol. 2023 Jan;21(1):229-231.e1. (PMID: 34793965)
Ther Adv Gastrointest Endosc. 2019 May 30;12:2631774519843401. (PMID: 31192315)
Chin J Cancer Res. 2017 Apr;29(2):127-136. (PMID: 28536491)
BMC Microbiol. 2009 Aug 23;9:175. (PMID: 19698173)
J Epidemiol. 2023 Jan 5;33(1):1-7. (PMID: 33907066)
Front Med (Lausanne). 2014 Jun 23;1:18. (PMID: 25705629)
Arch Microbiol. 2023 Aug 7;205(9):301. (PMID: 37550555)
Ann Transl Med. 2015 Jan;3(1):9. (PMID: 25705641)
World J Gastroenterol. 2013 Dec 7;19(45):8219-26. (PMID: 24363512)
PLoS One. 2021 Nov 24;16(11):e0260454. (PMID: 34818349)
Int J Med Microbiol. 2013 Dec;303(8):618-23. (PMID: 24103649)
Clin Vaccine Immunol. 2008 Nov;15(11):1705-10. (PMID: 18827192)
JPGN Rep. 2023 Oct 09;4(4):e374. (PMID: 38034459)
Proteomes. 2017 Oct 03;5(4):. (PMID: 28972560)
Gastroenterology. 1999 Feb;116(2):269-76. (PMID: 9922306)
BMC Infect Dis. 2022 Jun 25;22(1):573. (PMID: 35752757)
Clin Biochem. 2023 Nov;121-122:110656. (PMID: 37802380)
CA Cancer J Clin. 2024 May-Jun;74(3):229-263. (PMID: 38572751)
Front Med (Lausanne). 2023 Jan 12;9:1065045. (PMID: 36714104)
Gastroenterology. 2024 Apr;166(4):605-619. (PMID: 38176660)
Clin Diagn Lab Immunol. 2005 Jan;12(1):81-5. (PMID: 15642989)
Clin Microbiol Rev. 2007 Apr;20(2):280-322. (PMID: 17428887)
IARC Monogr Eval Carcinog Risks Hum. 1994;61:1-241. (PMID: 7715068)
World J Gastroenterol. 2014 May 7;20(17):5087-91. (PMID: 24803823)
World J Gastroenterol. 2018 Apr 7;24(13):1419-1428. (PMID: 29632423)
Syst Rev. 2025 May 9;14(1):107. (PMID: 40346683)
Sci Rep. 2019 Jan 10;9(1):38. (PMID: 30631092)
Grant Information: Hoang Long Pharma
Contributed Indexing: Keywords: CagA; FliD; H. pylori detection; Pylori DuoTect test; RUT; UBT
Substance Nomenclature: 0 (Antibodies, Bacterial)
0 (Antigens, Bacterial)
0 (Bacterial Proteins)
0 (cagA protein, Helicobacter pylori)
EC 3.5.1.5 (Urease)
Entry Date(s): Date Created: 20260811 Date Completed: 20260811 Latest Revision: 20260813
Update Code: 20260814
PubMed Central ID: PMC13457972
DOI: 10.1111/hel.70155
PMID: 42576348
Database: MEDLINE
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  Data: Diagnostic Value of the Pylori DuoTect Test for Helicobacter pylori Detection in the Vietnamese Population.
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  Data: <searchLink fieldCode="AU" term="%22Viet+HD%22">Viet HD</searchLink>; Internal Medicine Faculty, Hanoi Medical University, Hanoi, Vietnam.; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.; Endoscopy Centre, Hanoi Medical University Hospital, Hanoi, Vietnam.<br /><searchLink fieldCode="AU" term="%22Phuc+BN%22">Phuc BN</searchLink>; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.<br /><searchLink fieldCode="AU" term="%22Thi+TD%22">Thi TD</searchLink>; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.<br /><searchLink fieldCode="AU" term="%22Huyen+TNT%22">Huyen TNT</searchLink>; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.<br /><searchLink fieldCode="AU" term="%22Thu+TN%22">Thu TN</searchLink>; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.<br /><searchLink fieldCode="AU" term="%22Thu+UVT%22">Thu UVT</searchLink>; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.<br /><searchLink fieldCode="AU" term="%22Bao+LH%22">Bao LH</searchLink>; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.; College of Health Sciences, VinUniversity, Hanoi, Vietnam.<br /><searchLink fieldCode="AU" term="%22Van+LD%22">Van LD</searchLink>; Internal Medicine Faculty, Hanoi Medical University, Hanoi, Vietnam.; Institute of Gastroenterology and Hepatology, Hanoi, Vietnam.; Endoscopy Centre, Hanoi Medical University Hospital, Hanoi, Vietnam.
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– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Objectives: To evaluate the diagnostic accuracy in Helicobacter pylori detection using blood test with FliD and CagA antibodies (Pylori DuoTect), comparing with rapid urease test (RUT) and urease breath test (UBT) in Vietnamese patients with upper GI symptoms.<br />Methods: A cross-sectional study was conducted at the Institute of Gastroenterology and Hepatology in Hanoi, Vietnam on adults with upper GI symptoms, no prior treatment of peptic ulcers, and no history of H. pylori infection. Participants underwent upper GI endoscopy and three H. pylori tests, including rapid urease test (RUT), urea breath test (UBT), and Pylori DuoTect. Pylori DuoTect was considered positive if either FliD or CagA antibodies were detected. The H. pylori infection was defined as both RUT and UBT positive. Endoscopic findings were classified using the Kyoto classification score for gastritis. Diagnostic accuracy was evaluated using sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).<br />Results: From December 1, 2023, to August 9, 2024, 333 patients were recruited (mean age 45.9 years, 39.9% male). The most common symptom was epigastric pain (49.5%). The prevalences of gastritis, gastric ulcers, and duodenal ulcers were 92.7%, 12.1%, and 8.1%, respectively. Pylori DuoTect was positive in 51.9% of patients (FliD: 34.8% and CagA: 66.6%). Using the gold standard, 33.6% were diagnosed with H. pylori infection. The sensitivity, specificity, PPV, and NPV of Pylori DuoTect were 83.0%, 64.0%, 54.0%, and 88.0%, respectively. Combining Pylori DuoTect and endoscopy findings (peptic ulcer or Kyoto score ≥ 2) improved the sensitivity from 0.83 to 0.88 and increased NPV.<br />Conclusion: Pylori DuoTect had moderate sensitivity and low specificity in the diagnosis of H. pylori infection in Vietnamese adult patients.<br /> (© 2026 John Wiley & Sons Ltd.)
– Name: Ref
  Label: References
  Group: RefInfo
  Data: Clin Gastroenterol Hepatol. 2023 Jan;21(1):229-231.e1. (PMID: <searchLink fieldCode="PM" term="%2234793965%22">34793965)</searchLink><br />Ther Adv Gastrointest Endosc. 2019 May 30;12:2631774519843401. (PMID: <searchLink fieldCode="PM" term="%2231192315%22">31192315)</searchLink><br />Chin J Cancer Res. 2017 Apr;29(2):127-136. (PMID: <searchLink fieldCode="PM" term="%2228536491%22">28536491)</searchLink><br />BMC Microbiol. 2009 Aug 23;9:175. (PMID: <searchLink fieldCode="PM" term="%2219698173%22">19698173)</searchLink><br />J Epidemiol. 2023 Jan 5;33(1):1-7. (PMID: <searchLink fieldCode="PM" term="%2233907066%22">33907066)</searchLink><br />Front Med (Lausanne). 2014 Jun 23;1:18. (PMID: <searchLink fieldCode="PM" term="%2225705629%22">25705629)</searchLink><br />Arch Microbiol. 2023 Aug 7;205(9):301. (PMID: <searchLink fieldCode="PM" term="%2237550555%22">37550555)</searchLink><br />Ann Transl Med. 2015 Jan;3(1):9. (PMID: <searchLink fieldCode="PM" term="%2225705641%22">25705641)</searchLink><br />World J Gastroenterol. 2013 Dec 7;19(45):8219-26. (PMID: <searchLink fieldCode="PM" term="%2224363512%22">24363512)</searchLink><br />PLoS One. 2021 Nov 24;16(11):e0260454. (PMID: <searchLink fieldCode="PM" term="%2234818349%22">34818349)</searchLink><br />Int J Med Microbiol. 2013 Dec;303(8):618-23. (PMID: <searchLink fieldCode="PM" term="%2224103649%22">24103649)</searchLink><br />Clin Vaccine Immunol. 2008 Nov;15(11):1705-10. (PMID: <searchLink fieldCode="PM" term="%2218827192%22">18827192)</searchLink><br />JPGN Rep. 2023 Oct 09;4(4):e374. (PMID: <searchLink fieldCode="PM" term="%2238034459%22">38034459)</searchLink><br />Proteomes. 2017 Oct 03;5(4):. (PMID: <searchLink fieldCode="PM" term="%2228972560%22">28972560)</searchLink><br />Gastroenterology. 1999 Feb;116(2):269-76. (PMID: <searchLink fieldCode="PM" term="%229922306%22">9922306)</searchLink><br />BMC Infect Dis. 2022 Jun 25;22(1):573. (PMID: <searchLink fieldCode="PM" term="%2235752757%22">35752757)</searchLink><br />Clin Biochem. 2023 Nov;121-122:110656. (PMID: <searchLink fieldCode="PM" term="%2237802380%22">37802380)</searchLink><br />CA Cancer J Clin. 2024 May-Jun;74(3):229-263. (PMID: <searchLink fieldCode="PM" term="%2238572751%22">38572751)</searchLink><br />Front Med (Lausanne). 2023 Jan 12;9:1065045. (PMID: <searchLink fieldCode="PM" term="%2236714104%22">36714104)</searchLink><br />Gastroenterology. 2024 Apr;166(4):605-619. (PMID: <searchLink fieldCode="PM" term="%2238176660%22">38176660)</searchLink><br />Clin Diagn Lab Immunol. 2005 Jan;12(1):81-5. (PMID: <searchLink fieldCode="PM" term="%2215642989%22">15642989)</searchLink><br />Clin Microbiol Rev. 2007 Apr;20(2):280-322. (PMID: <searchLink fieldCode="PM" term="%2217428887%22">17428887)</searchLink><br />IARC Monogr Eval Carcinog Risks Hum. 1994;61:1-241. (PMID: <searchLink fieldCode="PM" term="%227715068%22">7715068)</searchLink><br />World J Gastroenterol. 2014 May 7;20(17):5087-91. (PMID: <searchLink fieldCode="PM" term="%2224803823%22">24803823)</searchLink><br />World J Gastroenterol. 2018 Apr 7;24(13):1419-1428. (PMID: <searchLink fieldCode="PM" term="%2229632423%22">29632423)</searchLink><br />Syst Rev. 2025 May 9;14(1):107. (PMID: <searchLink fieldCode="PM" term="%2240346683%22">40346683)</searchLink><br />Sci Rep. 2019 Jan 10;9(1):38. (PMID: <searchLink fieldCode="PM" term="%2230631092%22">30631092)</searchLink>
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              Text: 2026 Jul-Aug
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