Advertisement

Evaluation of a novel rapid one-step monoclonal chromatographic immunoassay for detection of Helicobacter pylori in stool from children

  • A. Schwarzer
  • C. Lottspeich
  • H. Rüssmann
  • G. Ossiander
  • S. KoletzkoEmail author
Article

Abstract

A new rapid office-based one-step monoclonal immunoassay (RAPID Hp StAR, DakoCytomation, Cambridge, UK) for detection of Helicobacter pylori antigen in stool was evaluated in children against invasive diagnostic methods and compared to the results of a monoclonal EIA targeting the same antigen (Amplified IDEIA Hp StAR, DakoCytomation, Cambridge, UK). Coded stool samples from 118 symptomatic children (0.3–18.8 years) were investigated prior to any anti-H. pylori therapy. Fifty-four children were H. pylori infected defined by positive culture and/or two other positive tests (13C- urea breath test, histology, rapid urea test), the remaining 64 children showed concordant negative results. Thirty-four infected children (4.8–17.8 years) were monitored with 13C- urea breath test (five remained positive) and stool test 6–8 weeks after anti-H. pylori therapy. The immunoassays were independently read by two investigators. The monoclonal EIA showed excellent sensitivity and specificity before (98% and 100%, respectively) and after therapy (100%; 96.2%). The rapid immunoassay was invalid for technical reasons in nine samples (5.9%). The two observers agreed in 31 positive and 93 negative results, but had discordant results in 17 samples (11.2%). Overall, the rapid test showed a poor sensitivity (63.8%–71.1%), but a good specificity (91.1%–96.2%) before treatment. We conclude that the new office based monoclonal enzyme immunoassay for diagnosis of H. pylori should be modified to improve sensitivity, inter-observer-variability and some technical problems. In contrast, the monoclonal EIA stool test is highly reliable, both pre- and post therapy, and equivalent to the 13C- urea breath test.

Keywords

Pylorus Infection Stool Sample Test Line Urea Breath Test Pylorus Status 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgment

The study was financially supported by DakoCytomation, UK.

References

  1. 1.
    Koletzko S (2005) Noninvasive diagnostic tests for Helicobacter pylori infection in children. Can J Gastroenterol 19:433–439PubMedGoogle Scholar
  2. 2.
    Kindermann A, Demmelmair H, Koletzko B, Krauss-Etschmann S, Wiebecke B, Koletzko S (2000) Influence of age on 13C-urea breath test results in children. J Pediatr Gastroenterol Nutr 30:85–91PubMedCrossRefGoogle Scholar
  3. 3.
    Oliveira AMR, Rocha GA, Queiroz DM, Mendes EN, de Carvalho AS, Ferrari TC, Nogueira AM (1999) Evaluation of enzyme-linked immunosorbent assay for the diagnosis of Helicobacter pylori infection in children from different age groups with and without duodenal ulcer. J Pediatr Gastroenterol Nutr 28:157–161PubMedCrossRefGoogle Scholar
  4. 4.
    Koletzko S, Feydt-Schmidt A (2001) Infants differ from teenagers: use of non-invasive tests for detection of Helicobacter pylori infection in children. Eur J Gastroenterol Hepatol 13:1047–1052PubMedCrossRefGoogle Scholar
  5. 5.
    Konstantopoulos N, Russmann H, Tasch C, Sauerwald T, Demmelmair H, Autenrieth I, Koletzko S (2001) Evaluation of the Helicobacter pylori stool antigen test (HpSA) for detection of Helicobacter pylori infection in children. Am J Gastroenterol 96:677–683PubMedCrossRefGoogle Scholar
  6. 6.
    Megraud F, European Task Force on Helicobacter pylori (2005) Comparison of non-invasive tests to detect Helicobacter pylori infection in children and adolescents: results of a multicentric European study. J Pediatr 146:198–203PubMedCrossRefGoogle Scholar
  7. 7.
    Makristathis A, Barousch W, Pasching E, Binder C, Kuderna C, Apfalter P, Rotter ML, Hirschl AM (2000) Two enzyme immunoassays and PCR for detection of Helicobacter pylori in stool specimens from pediatric patients before and after eradication therapy. J Clin Microbiol 38:3710–3714PubMedGoogle Scholar
  8. 8.
    Koletzko S, Konstantopoulos N, Bosman D, Feydt-Schmidt A, van der Ende A, Kalach N, Raymond J, Russmann H (2003) Evaluation of a novel monoclonal enzyme immunoassay for detection of Helicobacter pylori antigen in stool from children. Gut 52:804–806PubMedCrossRefGoogle Scholar
  9. 9.
    Rüssmann H, Kempf VAJ, Koletzko S, Heesemann J, Autenrieth IB (2001) Comparison of fluorecsent in situ hybridization and conventional culturing to detect Helicobacter pylori in gastric biopsies. J Clin Microbiol 39:304–308PubMedCrossRefGoogle Scholar
  10. 10.
    Drumm B, Koletzko S, Oderda G (2000) Helicobacter pylori infection in children: A consensus statement. J Pediatr Gastroenterol Nutr 30:207–213PubMedCrossRefGoogle Scholar
  11. 11.
    Kolho KL, Klemola T, Koivusalo A, Rautelin H (2006) Stool antigen tests for the detection of Helicobacter pylori in children. Diagn Microbiol Infect Dis 55:269–273PubMedCrossRefGoogle Scholar
  12. 12.
    Gisbert JP, Trapero M, Calvet X, Mendoza J, Quesada M, Güell M, Pajares JM (2004) Evaluation of three different tests for the detection of stool antigens to diagnose Helicobacter pylori infection in patients with upper gastrointestinal bleeding. Aliment Pharmacol Ther 19:923–929PubMedCrossRefGoogle Scholar
  13. 13.
    Leodolter A, Peitz U, Ebert MP, Agha-Amiri K, Malfertheiner P (2002) Comparison of two enzyme immunoassays for the assessment of Helicobacter pylori status in stool specimens after eradication therapy. Am J Gastroenterol 97:1682–1686PubMedCrossRefGoogle Scholar
  14. 14.
    Lopez T, Quesada M, Almirall J, Sanfeliu I (2004) Usefulness of non-invasive tests for diagnosing Helicobacter pylori infection in patients undergoing dialysis for chronic renal failure. Helicobacter 9:674–680PubMedCrossRefGoogle Scholar
  15. 15.
    Zambon CF, Basso D, Navaglia F, Mazza S, Razetti M, Fogar P, Greco E, Gallo N, Farinati F, Rugge M, Plebani M (2004) Non-invasive diagnosis of Helicobacter pylori infection: simplified 13C-urea breath test, stool antigen testing, or DNA PCR in human feces in a clinical laboratory setting? Clin Biochem 37:261–267PubMedCrossRefGoogle Scholar
  16. 16.
    Chisholm SA, Watson CL, Teare EL, Saverymuttu S, Owen RL (2004) Non-invasive diagnosis of Helicobacter pylori infection in adult dyspeptic patients by stool antigen detection: does the rapid immunochromatography test provide a reliable alternative to conventional ELISA kits? J Med Microbiol 53:623–627PubMedCrossRefGoogle Scholar
  17. 17.
    Antos D, Crone J, Konstantopoulos N, Koletzko S (2005) Evaluation of a novel rapid one-step immunochromatographic assay for detection of monoclonal Helicobacter pylori antigen in stool samples from children. J Clin Microbiol 43:2598–2601PubMedCrossRefGoogle Scholar
  18. 18.
    Kindermann A, Tasch C, Sauerwald T, Rüssmann H, Weigand H, Demmelmair H, Koletzko S (2000) Major differences of commercial ELISA to detect H. pylori infection in children. J Pediatr Gastroenterol Nutr 31(Suppl 2):S148Google Scholar
  19. 19.
    Imrie C, Rowland M, Bourke B, Drumm B (2001) Limitations to carbon 13-labeled urea breathe testing for Helicobacter pylori in infants. J Pediatr 139:734–737PubMedCrossRefGoogle Scholar
  20. 20.
    Konstantopoulos N, Koletzko S, Feydt-Schmidt A, Rüssmann H, Bosman DK, van der Ende A, Kalach N, Raymond J (2001) Detection of H. pylori antigen in stool with a novel monoclonal EIA (FemtoLab H.pylori Cnx). J Pediatr Gastroenterol Nutr 33:108CrossRefGoogle Scholar
  21. 21.
    van Doorn OJ, Bosman DK, van’t Hoff BW, Taminiau JA, ten Kate FJ, van der Ende A (2001) Helicobacter pylori stool antigen test: a reliable non-invasive test for the diagnosis of Helicobacter pylori infection in children. Eur J Gastroenterol Hepatol 13:1061–1065PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2007

Authors and Affiliations

  • A. Schwarzer
    • 1
  • C. Lottspeich
    • 2
  • H. Rüssmann
    • 2
  • G. Ossiander
    • 1
  • S. Koletzko
    • 1
    Email author
  1. 1.Dr. von Haunersches KinderspitalLudwig Maximilians University MunichMunichGermany
  2. 2.Max von Pettenkofer Institute for Hygiene and Medical MicrobiologyLudwig Maximilians University MunichMunichGermany

Personalised recommendations