Use of a receiver operating characteristic in the evaluation of two commercial enzyme immunoassays for detection ofHelicobacter pylori infection
- 25 Downloads
- 8 Citations
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.
Keywords
Receiver Operating Characteristic Pylorus Infection Enzyme Immunoassay Diagnostic System Individual ResultPreview
Unable to display preview. Download preview PDF.
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.PubMedGoogle Scholar
- 3.Goodwin CS: Gastric cancer andHelicobacter pylori: the whispering killer? Lancet 1993, 342: 507–508.CrossRefPubMedGoogle 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.CrossRefPubMedGoogle 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.CrossRefGoogle 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.PubMedGoogle 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.PubMedGoogle 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.CrossRefGoogle 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.PubMedGoogle 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.PubMedGoogle Scholar
- 12.Vogt K, Hahn H: Urease production byHelicobacter (Campylobacter) pylori. Zentralblatt für Bakteriologie 1991, 275: 63–72Google 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.PubMedGoogle 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.PubMedGoogle 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.CrossRefPubMedGoogle 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.PubMedGoogle 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.CrossRefPubMedGoogle 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.CrossRefGoogle 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.PubMedGoogle 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.PubMedGoogle 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.PubMedGoogle 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.PubMedGoogle 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.PubMedGoogle 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.PubMedGoogle 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.CrossRefGoogle 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.CrossRefGoogle 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.PubMedGoogle Scholar
- 31.Schembri MA, Lin SK, Lambert JR: Comparison of commercial diagnostic tests forHelicobacter pylori antibodies. Journal of Clinical Microbiology 1993, 31: 2621–2624.PubMedGoogle 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.PubMedGoogle Scholar
- 33.Meyer-Wyss B, Beglinger C, Baselgia L, Merki H, Renner E:Helicobacter infection in healthy people. Gut 1993, 34: 1429PubMedGoogle 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.PubMedGoogle 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.CrossRefGoogle 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.PubMedGoogle 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.CrossRefPubMedGoogle Scholar