Skip to main content
Log in

Use of a receiver operating characteristic in the evaluation of two commercial enzyme immunoassays for detection ofHelicobacter pylori infection

  • Article
  • Published:
European Journal of Clinical Microbiology and Infectious Diseases Aims and scope Submit manuscript

Abstract

Two novel commercial IgG enzyme immunoassay (EIA) systems based on acid-glycine-extracted (Pyloriset IgG EIA, Orion Diagnostica) or fast protein liquid chromatography-purified (Cobas Core Anti-H. pylori EIA, Roche Diagnostic Systems)Helicobacter antigens were evaluated in a prospective study involving 127 patients. All patients underwent upper endoscopy with biopsy, and biopsies were examined for the presence ofHelicobacter pylori by a rapid urease test, microscopy and culture. Of the 71 patients found to be infected withHelicobacter pylori, 69 (97.2 %) and 65 (91.5 %) tested positive with the Cobas Core and Pyloriset test, respectively. A detailed receiver operating characteristic analysis of the two tests showed that the Cobas Core assay was more sensitive and specific at every possible cut-off level; gave a better resolution of individual results, indicating a greater fine-sensitivity; and had no grey zone compared to a large grey zone encompassing 13.4 % of the serum samples tested with the Pyloriset EIA. The Cobas Core assay appears to be a valuable tool for epidemiological purposes as well as for pre-endoscopic screening of dyspeptic patients.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Warren JR, Marshall BJ: Unidentified curved bacilli on gastric epithelium in active chronic gastritis. Lancet 1983, i: 1273–1275.

    Google Scholar 

  2. Labenz J, Börsch G: Evidence for the essential role ofHelicobacter pylori in gastric ulcer disease. Gut 1994, 35: 19–22.

    PubMed  Google Scholar 

  3. Goodwin CS: Gastric cancer andHelicobacter pylori: the whispering killer? Lancet 1993, 342: 507–508.

    Article  PubMed  Google Scholar 

  4. Wotherspoon AC, Doglioni C, Diss TC, Pan L, Moschini A, de Boni M, Isaacson PG: Regression of primary low-grade B-cell lymphoma of mucosa-associated lymphoid tissue type after eradication ofHelicobacter pylori. Lancet 1993, 342: 575–577.

    Article  PubMed  Google Scholar 

  5. Graham DY, Klein PD, Evans DJ Jr, Evans DG, Alpert LC, Opekun AR, Boutton TW:Campylobacter pylori detected noninvasively by the13C-urea breath test. Lancet 1987, i: 1174–1177.

    Article  Google Scholar 

  6. Marshall BJ, Surveyer I: Carbon-14 urea breath test for the diagnosis ofCampylobacter pylori associated gastritis. Journal of Nuclear Medicine 1988, 29: 11–16.

    PubMed  Google Scholar 

  7. Jones DM, Lessels AM, Eldridge J:Campylobacter-like organisms on the gastric mucosa: culture, histology, and serological studies. Journal of Clinical Pathology 1984, 37: 1002–1006.

    PubMed  Google Scholar 

  8. von Wulffen H: An assessment of serological tests for detection ofHelicobacter pylori. European Journal of Clinical Microbiology and Infectious Diseases 1992, 11: 577–582.

    Article  Google Scholar 

  9. Hanley JA, McNeil BJ: The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology 1982, 143: 29–36.

    PubMed  Google Scholar 

  10. Vogt K, Warrelmann M, Hahn H: The minimum inhibitory concentrations of various bismuth salts againstCampylobacter pylori. Zentralblatt für Bakteriologie 1989, 271: 304–310.

    Google Scholar 

  11. Befrits R, Granström M, Rylander M, Rubio C:Helicobacter pylori in 205 consecutive endoscopy patients. Scandinavian Journal of Infectious Diseases 1993, 25: 185–191.

    PubMed  Google Scholar 

  12. Vogt K, Hahn H: Urease production byHelicobacter (Campylobacter) pylori. Zentralblatt für Bakteriologie 1991, 275: 63–72

    Google Scholar 

  13. Thomas JE, Whatmore AM, Barer MR, Eastham EDJ, Kehoe MA: Serodiagnosis ofHelicobacter pylori infection in childhood. Journal of Clinical Microbiology 1990, 28: 2641–2646.

    PubMed  Google Scholar 

  14. von Wulffen H, Grote HJ, Gatermann S, Löning T, Berger B: Immunoblot analysis of immune response toCampylobacter pylori and its clinical associations. Journal of Clinical Pathology 1988, 41: 653–659.

    PubMed  Google Scholar 

  15. Kuipers EJ, Pena AS, van Kamp G, Uyterlinde AM, Pals G, Pels NFM, Kurz-Pohlmann E, Meuwissen SGM: Seroconversion forHelicobacter pylori. Lancet 1993, 342: 328–331.

    Article  PubMed  Google Scholar 

  16. Sachs L: Angewandte Statistik. Springer, Berlin 1988, p. 64–65, 309–310.

    Google Scholar 

  17. Apel I, Jacobs E, Kist M, Bredt W: Antibody response of patients against a 120 KDa surface protein ofCampylobacter pylori. Zentralblatt für Bakteriologie und Hygiene (A) 1988, 268: 271–276.

    Google Scholar 

  18. Bäßler HMS, Dreher RM, Wolf K: Isolierung vonH. pylori-Proteinen und Beurteilung ihrer Eignung für den Einsatz in serologischen Diagnosesystemen. Immunität und Infektion 1992, 20: 103–106.

    Google Scholar 

  19. Granberg C, Mansikka A, Lehtonen OP, Kujari H, Grönfors R, Nurmi H, Räihä I, Stahlberg MR, Leino R: Diagnosis ofHelicobacter pylori infection by using Pyloriset EIA-G and EIA-A for detection of serum immunoglobulin G (IgG) and IgA antibodies. Journal of Clinical Microbiology 1993, 31: 1450–1453.

    PubMed  Google Scholar 

  20. Kosunen TU, Seppälä K, Sarna S, Sipponen P: Diagnostic value of decreasing IgG, IgA, and IgM antibody titres after eradication ofHelicobacter pylori. Lancet 1992, 339: 893–895.

    Article  PubMed  Google Scholar 

  21. Glupczynski Y, Burette A, Goossens H, DePrez C, Butzler JP: Effect of antimicrobial therapy on the specific serological response toHelicobacter pylori infection. European Journal of Clinical Microbiology and Infectious Diseases 1992, 11: 583–588.

    Article  Google Scholar 

  22. Hirschl AM, Brandstätter G, Dragosics B, Hentschel E, Kundi M, Rotter ML, Schütze K, Taufer M: Kinetics of specific IgG antibodies for monitoring the effect of anti-Helicobacter pylori chemotherapy. Journal of Infectious Diseases 1993, 168: 763–766.

    PubMed  Google Scholar 

  23. Newell DG: Identification of the outer membrane proteins ofCampylobacter pyloridis and antigenic cross-reactivity betweenC. pyloridis andC. jejuni. Journal of General Microbiology 1987, 133: 163–170.

    PubMed  Google Scholar 

  24. Lee A, Logan SM, Trust TJ: Demonstration of a flagellar antigen shared by a diverse group of spiral shaped bacteria that colonize intestinal mucus. Infection and Immunity 1987, 55: 828–831.

    PubMed  Google Scholar 

  25. Evans DJ Jr, Evans DG, Smith KE, Graham DY: Serum antibody responses to the N-acetylneuraminyl-lactose-binding hemagglutinin ofCampylobacter pylori. Infection and Immunity 1989, 57: 664–667.

    PubMed  Google Scholar 

  26. Lelwala-Guruge J, Nilsson I, Ljungh A, Wadström T: Cell surface proteins ofHelicobacter pylori as antigens in an ELISA and a comparison with three commercial ELISA. Scandinavian Journal of Infectious Diseases 1992, 24: 457–465.

    PubMed  Google Scholar 

  27. Hirschl AM, Rathbone BJ, Wyatt JI, Berger J, Rotter ML: Comparison of ELISA antigen preparations alone or in combination for serodiagnosingHelicobacter pylori infections. Journal of Clinical Pathology 1990, 43: 511–513.

    PubMed  Google Scholar 

  28. Gerstenecker B, Eschweiler B, Vögele H, Koch HK, Hellerich U, Kist M: Serodiagnosis ofHelicobacter pylori infections with an enzyme immunoassay using the chromatographically purified 120 kilodalton protein. European Journal of Clinical Microbiology and Infectious Diseases 1992, 11: 595–601.

    Article  Google Scholar 

  29. Clayton CL, Kleanthous H, Dent JC, McNulty CAM, Tabaqchali S: Evaluation of fingerprinting methods for identification ofHelicobacter pylori strains. European Journal of Clinical Microbiology and Infectious Diseases 1991, 10: 1040–1047.

    Article  Google Scholar 

  30. Dunn BE, Campell GP, Perez-Perez GI, Blaser MJ: Purification and characterization of urease fromHelicobacter pylori. Journal of Biological Chemistry 1990, 265: 9464–9469.

    PubMed  Google Scholar 

  31. Schembri MA, Lin SK, Lambert JR: Comparison of commercial diagnostic tests forHelicobacter pylori antibodies. Journal of Clinical Microbiology 1993, 31: 2621–2624.

    PubMed  Google Scholar 

  32. Goossens H, Glupczynski Y, Burette A, Van den Borre C, Butzler JP: Evaluation of a commercially available second-generation immunoglobulin G enzyme immunoassay for detection ofHelicobacter pylori infection. Journal of Clinical Microbiology 1992, 30: 176–180.

    PubMed  Google Scholar 

  33. Meyer-Wyss B, Beglinger C, Baselgia L, Merki H, Renner E:Helicobacter infection in healthy people. Gut 1993, 34: 1429

    PubMed  Google Scholar 

  34. Debongnie JC, Durez P, Luyasu V: Validation et usage clinique et épidémiologique d'un test sérologique commercialisé dans le diagnostic de l'infection àHelicobacter pylori. Gastroenterologie Clinique et Biologique 1993, 17: 98–102.

    PubMed  Google Scholar 

  35. Aguirre PM, Pascual CY, Merin FJ, Velasco AC: Evaluation of two commercial enzyme immunoassays for the diagnosis ofHelicobacter pylori infection. European Journal of Clinical Microbiology and Infectious Diseases 1992, 11: 634–639.

    Article  Google Scholar 

  36. Glupczynski Y. Goossens H, Burette A, Deprez C, van Borre C, Butzler JP: Serology inHelicobacter pylori infection. Zentralblatt für Bakteriologie 1993, 280: 150–154.

    Google Scholar 

  37. Evans DJ, Evans DG, Graham DY, Klein PD: A sensitive and specific serologic test for detection ofCampylobacter pylori infection. Gastroenterology 1989, 96: 1004–1008.

    PubMed  Google Scholar 

  38. Sobala GM, Crabtree JE, Pentith JA, Rathborne BJ, Shallcross TM, Wyatt JI, Dixon MF, Heatley RV, Axon ATR: Screening dyspepsia by serology toHelicobacter pylori. Lancet 1991, 338: 94–96.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Trautmann, M., Moldrzyk, M., Vogt, K. et al. Use of a receiver operating characteristic in the evaluation of two commercial enzyme immunoassays for detection ofHelicobacter pylori infection. Eur. J. Clin. Microbiol. Infect. Dis. 13, 812–819 (1994). https://doi.org/10.1007/BF02111341

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF02111341

Keywords

Navigation