Evidence map›Paper›PMID 36263754›Full record

ArticleHelicobacter2022

Clinical evaluation of a novel molecular diagnosis kit for detecting Helicobacter pylori and clarithromycin-resistant using intragastric fluid.

Momoko Tsuda, Yoshiyuki Watanabe, Ritsuko Oikawa, Ryosuke Watanabe, Masayuki Higashino, Kimitoshi Kubo, Hiroyuki Yamamoto, Fumio Itoh, Mototsugu Kato

Abstract read
In one paragraph

Article in Helicobacter, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Guideline
  3. CurrentJGH open : an open access journal of gastroenterology and hepatology · 2026
    Review
  4. Atypical acuteFujita medical journal · 2026
    Article
  5. Review
  6. Helicobacter pylori Management in Older Adults: Current Perspectives From Japan.The Korean journal of helicobacter and upper gastrointestinal research · 2026
    Review
  7. Article
  8. Methodological evaluation ofFrontiers in cellular and infection microbiology · 2026
    Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Asia-Pacific Survey on the Management of Helicobacter pylori Infection.Journal of gastroenterology and hepatology · 2025
    Article
  14. Article
  15. Review
  16. Clinical evaluation of a novelFrontiers in cellular and infection microbiology · 2025
    Observational
  17. Review
  18. Antibiotic resistance ofFrontiers in cellular and infection microbiology · 2023
    Article
  19. Article
  20. Article
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.

Momoko TsudaDepartment of Gastroenterology, National Hospital Organization Hakodate National Hospital, Hakodate, Japan.ORCID https://orcid.org/0000-0002-2396-8036
Yoshiyuki WatanabeDepartment of Internal Medicine, Kawasaki Rinko General Hospital, Kawasaki, Japan.ORCID https://orcid.org/0000-0001-9037-3596
Ritsuko OikawaDivision of Gastroenterology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.
Ryosuke WatanabeDepartment of Gastroenterology, National Hospital Organization Hakodate National Hospital, Hakodate, Japan.
Masayuki HigashinoDepartment of Gastroenterology, National Hospital Organization Hakodate National Hospital, Hakodate, Japan.
Kimitoshi KuboDepartment of Gastroenterology, National Hospital Organization Hakodate National Hospital, Hakodate, Japan.ORCID https://orcid.org/0000-0002-1424-1011
Hiroyuki YamamotoDivision of Gastroenterology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.ORCID https://orcid.org/0000-0002-0954-6806
Fumio ItohDivision of Gastroenterology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.
Mototsugu KatoDepartment of Gastroenterology, National Hospital Organization Hakodate National Hospital, Hakodate, Japan.ORCID https://orcid.org/0000-0001-7913-8384

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough there are many Helicobacter pylori (H. pylori) diagnostic methods, the culture and antibiotic susceptibility test is an important method for selecting the most effective H. pylori eradication regimen. However, this diagnostic method is complicated and takes several days; therefore, the development of a rapid and simple diagnostic method is required. Eradication failure due to clarithromycin (CAM) resistance should also be considered. In this study, we report the clinical evaluation of point-of-care testing (POCT) kit using intragastric fluid, a novel kit for detecting H. pylori and CAM resistance. MATERIALS AND

methodsThe study participants were 143 patients suspected of H. pylori infection and had an endoscopic examination. The novel diagnostic kit diagnosed H. pylori infection and CAM resistance-associated mutation using intragastric fluid. To diagnose H. pylori infection, the relationship between the diagnostic kit and conventional diagnostic methods (urea breath test, stool antigen test, culture test, and real-time polymerase chain reaction [PCR]) was evaluated. For CAM resistance-associated mutation detection, the concordance between the diagnostic kit and antibiotic susceptibility test was evaluated.

resultsThe diagnosis of H. pylori infection with the novel molecular diagnostic kit using intragastric fluid showed significant relationship with conventional diagnostic methods. Especially when the culture was control, the sensitivity was 100% (67/67), the specificity was 95.9% (71/74), and the overall concordance was 97.9% (138/141). The detection of CAM resistance-associated mutations had a concordance rate of 97.0% (65/67) when compared with the antibiotic susceptibility test.

conclusionsThe H. pylori molecular POCT kit uses intragastric fluid as a sample and can diagnose H. pylori infection and detect CAM resistance-associated mutations within an hour. This novel kit is expected to prove useful in selecting the most effective eradication regimen for H. pylori.

Indexed as

Helicobacter InfectionsHelicobacter pyloriAnti-Bacterial AgentsClarithromycinDrug Resistance, BacterialHumansMicrobial Sensitivity TestsAnti-Bacterial AgentsClarithromycingastric juiceH. pylori diagnosisPCRpoint-of-care testingsusceptibility test

Identifiers

PMID36263754
PMCPMC9788249

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.