Evidence map›Paper›PMID 24006137›Full record

ArticleClinical and vaccine immunology : CVI2013

A novel line immunoassay based on recombinant virulence factors enables highly specific and sensitive serologic diagnosis of Helicobacter pylori infection.

Luca Formichella, Laura Romberg, Christian Bolz, Michael Vieth, Michael Geppert, Gereon Göttner, Christina Nölting, Dirk Walter, Wolfgang Schepp, Arne Schneider and 5 more

Open access · diamondAbstract readValidation Study
In one paragraph

Article in Clinical and vaccine immunology : CVI, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 12% of its field
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

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. First regional consensus on the management ofWorld journal of gastroenterology · 2025
    Guideline
  2. Non-invasive diagnostic tests for Helicobacter pylori infection.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Potential pathogenesis ofFuture science OA · 2026
    Article
  4. Conventional Upper-Intestinal Endoscopy Value in Predicting Histopathological Features Related toJGH open : an open access journal of gastroenterology and hepatology · 2025
    Article
  5. Article
  6. Article
  7. RecombinantAntibiotics (Basel, Switzerland) · 2022
    Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Differences inJournal of clinical biochemistry and nutrition · 2019
    Article
  14. Validation of a Blood Biomarker for Identification of Individuals at High Risk for Gastric Cancer.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2018
    Article
  15. Article
  16. Article
  17. Article
  18. Cut-off optimization forScientific reports · 2017
    Article
  19. Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2017
    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

15 authors at 3 institutions in 1 country.

Luca FormichellaInstitute for Medical Microbiology, Immunology and Hygiene, Technische Universität München, Munich, Germany.
Laura Romberg
Christian Bolz
Michael Vieth
Michael Geppert
Gereon Göttner
Christina Nölting
Dirk Walter
Wolfgang Schepp
Arne Schneider
Kurt Ulm
Petra Wolf
Dirk H Busch
Erwin Soutschek
Markus Gerhard
Technical University of Munich · DEBayreuth Medical Center · DEMünchen Klinik Bogenhausen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Helicobacter pylori colonizes half of the world's population, and infection can lead to ulcers, gastric cancer, and mucosa-associated lymphoid tissue (MALT) lymphoma. Serology is the only test applicable for large-scale, population-based screening, but current tests are hampered by a lack of sensitivity and/or specificity. Also, no serologic test allows the differentiation of type I and type II strains, which is important for predicting the clinical outcome. H. pylori virulence factors have been associated with disease, but direct assessment of virulence factors requires invasive methods to obtain gastric biopsy specimens. Our work aimed at the development of a highly sensitive and specific, noninvasive serologic test to detect immune responses to important H. pylori virulence factors. This line immunoassay system (recomLine) is based on recombinant proteins. For this assay, six highly immunogenic virulence factors (CagA, VacA, GroEL, gGT, HcpC, and UreA) were expressed in Escherichia coli, purified, and immobilized to nitrocellulose membranes to detect serological immune responses in patient's sera. For the validation of the line assay, a cohort of 500 patients was screened, of which 290 (58.0%) were H. pylori negative and 210 (42.0%) were positive by histology. The assay showed sensitivity and specificity of 97.6% and 96.2%, respectively, compared to histology. In direct comparison to lysate blotting and enzyme-linked immunosorbent assay (ELISA), the recomLine assay had increased discriminatory power. For the assessment of individual risk for gastrointestinal disease, the test must be validated in a larger and defined patient cohort. Taking the data together, the recomLine assay provides a valuable tool for the diagnosis of H. pylori infection.

Indexed as

Antigens, BacterialVirulence FactorsAdolescentAdultAgedAged, 80 and overAntibodies, BacterialDiagnostic Tests, RoutineEscherichia coliFemaleGene ExpressionHelicobacter InfectionsHelicobacter pyloriHumansImmunoassayMaleAntibodies, BacterialAntigens, BacterialRecombinant ProteinsVirulence Factors

Identifiers

PMID24006137
PMCPMC3837778
OpenAlexW2163110059

What OpenQuestion holds

Textmetadata
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.