The sera of 142 Helicobacter pylori-positive and 32 H. pylori-negative patients were assessed by a desktop test (QuickVue), an enzyme-linked immunosorbent assay (ELISA) (HM-CAP), and a solid-phase, two-step chemiluminescent enzyme immunoassay (Immulite). These tests yielded sensitivities of 97, 97, and 91% and specificities of 97, 94, and 100%, respectively. In conclusion, the desktop test and the ELISA are more sensitive than the chemiluminescent enzyme immunoassay (P <0.05). The chemiluminescent enzyme immunoassay has the advantage that it is fully automate

Dankert, J.

Roorda, P.L.H.

Tytgat, G.N.J.

van der Ende, A.

van der Hulst, R.W.M.

PubMed

International Migration, Integration and Social Cohesion online publications

UvA-DARE is a service provided by the library of the University of Amsterdam (https://dare.uva.nl)UvA-DARE (Digital Academic Repository)Evaluation of three commercial serological tests with different methodologies toassess Helicobacter pylori infectionvan der Ende, A.; van der Hulst, R.W.M.; Roorda, P.L.H.; Tytgat, G.N.J.; Dankert, J.Publication date1999Published inJournal of Clinical MicrobiologyLink to publicationCitation for published version (APA):van der Ende, A., van der Hulst, R. W. M., Roorda, P. L. H., Tytgat, G. N. J., & Dankert, J.(1999). Evaluation of three commercial serological tests with different methodologies toassess Helicobacter pylori infection. Journal of Clinical Microbiology, 37, 4150-4152.General rightsIt is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s)and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an opencontent license (like Creative Commons).Disclaimer/Complaints regulationsIf you believe that digital publication of certain material infringes any of your rights or (privacy) interests, pleaselet the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the materialinaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letterto: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. Youwill be contacted as soon as possible.Download date:11 Feb 2023JOURNAL OF CLINICAL MICROBIOLOGY,0095-1137/99/$04.0010Dec. 1999, p. 4150–4152 Vol. 37, No. 12Copyright © 1999, American Society for Microbiology. All Rights Reserved.Evaluation of Three Commercial Serological Tests with DifferentMethodologies To Assess Helicobacter pylori InfectionA. VAN DER ENDE,1* R. W. M. VAN DER HULST,2,3† P. ROORDA,1 G. N. J. TYTGAT,2 AND J. DANKERT1Department of Medical Microbiology1 and Department of Gastroenterology,2Academic Medical Center, Amsterdam, The NetherlandsReceived 19 April 1999/Returned for modification 21 August 1999/Accepted 7 September 1999The sera of 142 Helicobacter pylori-positive and 32 H. pylori-negative patients were assessed by a desktop test(QuickVue), an enzyme-linked immunosorbent assay (ELISA) (HM-CAP), and a solid-phase, two-step chemi-luminescent enzyme immunoassay (Immulite). These tests yielded sensitivities of 97, 97, and 91% and speci-ficities of 97, 94, and 100%, respectively. In conclusion, the desktop test and the ELISA are more sensitive thanthe chemiluminescent enzyme immunoassay (P < 0.05). The chemiluminescent enzyme immunoassay has theadvantage that it is fully automated.Helicobacter pylori infection in humans is one of the mostwidespread infections today, and its cure prevents peptic ulcerrecurrence (11). Besides chronic gastritis and peptic ulcer dis-ease, H. pylori infection is strongly associated with gastric can-cer and cancer of mucosa-associated lymphoid tissue (2, 3, 6)and is diagnosed by culturing of gastric biopsy specimens. Non-invasive tests like the urea breath test and tests based onserology may be an alternative for assessing H. pylori infection(1, 4, 8). Serology tests can be based on either the detection ofH. pylori antigens in the feces of patients or anti-H. pyloriantibodies in the patients’ blood or saliva (8, 9). The exact roleof serology in the management of H. pylori infection has still tobe defined, although there is evidence that, used as a screeningprocedure, it can reduce endoscopy cost and workload (10, 13).The aim of this study was to evaluate the sensitivity and spec-ificity of three commercially available serology tests, each witha different methodology to assess H. pylori infection. The desk-top test (QuickVue; Quidel, San Diego, Calif.) is a one-steptest that was originally designed to be used as a whole-bloodtest but can also be used for serum specimens. The results canbe read 10 min after the submission of the sample to the test.The HM-CAP test (Enteric Products, Inc., Stony Brook, N.Y.)is a standard enzyme-linked immunosorbent assay (ELISA).Sera are added to wells, precoated with H. pylori antigens, in a96-well microtiter plate. The test is completed, including read-ing of the results, within 1 h. This ELISA is qualitative and usescalibration sera to convert absorbance to arbitrary values. TheImmulite test (Diagnostic Products Corporation, Los Angeles,Calif.) is a solid-phase, two-step chemiluminescent enzymeimmunoassay. The solid phase, a polystyrene bead enclosedwithin a test unit, is coated with partially purified H. pyloriantigen. The diluted serum sample and a protein-based bufferare simultaneously introduced into the test unit and incubatedfor approximately 30 min with intermittent agitation. Duringthis time, H. pylori-specific immunoglobulin G (IgG) will bindto the antigen-coated bead. Unbound serum is then removedby washing by means of centrifugation. An alkaline phospha-tase-labeled anti-human IgG is introduced, and the test unit isincubated for another 30-min cycle. Again, the unbound con-jugate is removed by a centrifugal wash. Then the chemilumi-nescent substrate is added, and the test unit is incubated for afurther 10 min. The chemiluminescent substrate, a phosphateester of adamantyl dioxetane, undergoes hydrolysis in the pres-ence of alkaline phosphatase to yield an unstable intermediate.The continuous production of this intermediate results in thesustained emission of light, thus improving precision by pro-viding a window for multiple readings. The bound complex andthus also the photon output, as measured by the luminometer,are related to the presence of anti-H. pylori IgG in the sample.A qualitative result is then obtained by comparing the patientserum result to an established cutoff. This system automaticallyhandles the serum sample and reagent additions, the incuba-tion and separation steps, and measurement of the photonoutput via the temperature-controlled luminometer. Test re-sults for controls and patient samples are obtained from com-parison of the observed signal with a cutoff derived from theadjuster’s response and the bar-coded parameters. A printedreport is generated after completion of the test.(Part of this work was presented at the 98th General Meet-ing of the American Society for Microbiology [10a]).One hundred forty-two H. pylori-infected dyspeptic adults(70 with peptic ulcer disease and 72 with gastritis only) under-went gastroduodenoscopy at the Department of Gastroenter-ology in the Academic Medical Center, Amsterdam, The Neth-erlands (12). During each endoscopic procedure, three antraland three corpus mucosal biopsy specimens were obtained byuse of sterile biopsy forceps. One antrum and one corpusbiopsy specimen were placed in 2 ml of phosphate-buffered* Corresponding author. Mailing address: Department of MedicalMicrobiology, Academic Medical Center, University of Amsterdam,P.O. Box 22700, 1100 DE Amsterdam, The Netherlands. Phone: 31-20-5664862. Fax: 31-20-6979271.† Present address: Kennemer Gasthuis, Department of InternalMedicine, Gastroenterology, 2023 EA Haarlem, The Netherlands.TABLE 1. Sensitivity, specificity, and positive and negativepredictive values of three H. pylori serology testsaTest used Sensitivity SpecificityPositivepredictivevalueNegativepredictivevalueDesktop 97 (138/142) 97 (31/32) 99 (138/139) 89 (31/35)ELISA 97 (138/142) 94 (30/32) 99 (138/140) 88 (30/34)Two-step solidphase91 (129/142) 100 (32/32) 100 (129/129) 71 (32/45)a Values are shown as percentages (number of samples correctly identified/total number of samples).4150saline at 4°C and used for bacteriological culturing. The otherfour specimens were fixed in 10% formalin for histopatholog-ical examination. Cultures were prepared by smearing biopsyspecimens on the surface of horse blood agar plats (7% defi-brinated horse blood Columbia agar base; Oxoid CM 331;Unipath, Basingstoke, England) and horse blood agar platescontaining Skirrow supplement (Unipath). H. pylori organismswere identified on the basis of typical colony morphology;characteristic appearance on Gram staining; and positive ure-ase, oxidase, and catalase tests. H. pylori infection was presentif either culture and histopathological assessment or only his-topathology assessment was positive. Controls were 32 nonin-fected patients. They had H. pylori-negative cultures and nor-mal histopathology of multiple gastric biopsy specimens for atleast 4 years prior to serological testing. Blood was drawn fromthe H. pylori-positive patients and from the H. pylori-negativecontrols by venous puncture. After clotting, serum was storedat 270°C in small aliquots. Sera were assessed by the threedifferent serology tests according to the manufacturers’ proto-cols. The results obtained with the three different tests with thesera from 142 H. pylori-positive patients and 32 H. pylori-neg-ative patients are presented in Table 1. The sensitivities of theQuickVue, the HM-CAP, and the Immulite tests were 97, 97,and 91%, respectively (Table 1) (P , 0.05). The three tests hadspecificities of 97, 94, and 100%, respectively (not significant).The positive predictive values of the three tests were 99, 99,and 100%, respectively. The negative predictive values of thetests were 89, 88, and 71%, respectively (differences not sig-nificant). The sensitivity values of the ELISA and the desktoptest were in the same range as those reported by others (4, 5).The specificity of the tests in this study was somewhat higher.This may be explained by the H. pylori-negative controls in-cluded in this study. The subjects in this group were H. pylorinegative by culture and histopathology over a prolonged pe-riod of at least 4 years. This significantly diminishes the chanceof finding serological false positives in this group, because theconcentration of anti-H. pylori antibodies, elicited by a pos-sible infection prior to the H. pylori-negative period, wouldbe strongly reduced during that H. pylori-negative period.The desktop test is designed to be used as a whole-blood testand awaits evaluation as such, especially in a primary caresetting. In contrast to the QuickVue test, the HM-CAP andImmulite tests provide quantitative data (Fig. 1). The dy-namic range of the Immulite test is wider than that of theHM-CAP test, which may be beneficial for posttreatmentevaluation.In conclusion, the three serology tests are sensitive and spe-cific tests to assess H. pylori infection. The desktop test and theELISA are more sensitive than the chemiluminescent enzymeimmunoassay, but the QuickVue desktop test provides onlyqualitative results. However, the desktop test has the advan-tage of obtaining results within minutes. The ELISA HM-CAPand the chemiluminescent enzyme immunoassay Immulite areboth quantitative, but the latter test has the advantage thatsample handling, reading, and interpretation are fully auto-mated. The design of the Immulite test, i.e., accurate quanti-fication by using internal controls and a wide dynamic range inoutput values, makes it potentially suitable to assess H. pylorieradication by comparison of the patient’s pretreatment serumwith the posttreatment serum.REFERENCES1. Bazzoli, F., M. Zagari, S. Fossi, P. Pozzato, L. Ricciardiello, C. Mwangemi,A. Roda, and E. Roda. 1997. Urea breath tests for the detection of Helico-bacter pylori infection. Helicobacter 2(Suppl. 1):S34–S37.2. Blaser, M. J., G. I. Perez-Perez, and H. Kleanthous. 1995. Infection withHelicobacter pylori strains possessing cagA associated with an increasedrisk of developing adenocarcinoma of the stomach. Cancer Res. 55:2111–2115.3. Foreman, D., and the Eurogast Study Group. 1993. An international asso-ciation between Helicobacter pylori infection and gastric cancer. Lancet 341:359–362.4. Laheij, R. J. F., H. Straatman, J. B. M. J. Jansen, and A. L. M. Verbeek.1998. Evaluation of commercially available Helicobacter pylori kits: a review.J. Clin. Microbiol. 36:2803–2809.5. Meijer, B. C., J. C. Thijs, J. H. Kleibeuker, A. A. van Zwet, and R. J.Berrelkamp. 1997. Evaluation of eight enzyme immunoassays for detectionof immunoglobulin G against Helicobacter pylori. J. Clin. Microbiol. 35:292–294.6. Parsonnet, J., S. Hansen, L. Rodriguez, A. B. Gelb, R. A. Warnke, E. Jellum,N. Orentreich, J. H. Vogelman, and G. D. Friedman. 1994. Helicobacter pyloriinfection and gastric lymphoma. N. Engl. J. Med. 330:1267–1271.7. Savarino, V., S. Vigneri, and G. Celle. 1999. The 13C urea breath test in thediagnosis of Helicobacter pylori. Gut 45(Suppl. 1):118–122.8. Vaira, D., J. Holton, M. Menegatti, C. Ricci, F. Landi, A. Ali’, L. Gatta, C.Acciardi, S. Farinelli, M. Crosatti, S. Berardi, and M. Miglioli. 1999. Newimmunological assays for the diagnosis of Helicobacter pylori infection. Gut45(Suppl. 1):123–127.9. Vaira, D., P. Malfertheiner, F. Megraud, A. T. Axon, M. Deltenre, A. M.Hirschl, G. Gasbarrini, C. O’Morain, J. M. Garcia, M. Quina, and G. N.Tytgat. 1999. Diagnosis of Helicobacter pylori infection with a new non-invasive antigen-based assay. HpSA European study group. Lancet 354:30–33.10. Vaira, D., J. Holton, M. Menegatti, F. Landi, C. Ricci, A. Ali’, L. Gatta, S.Farinelli, C. Acciardi, M. Massardi, and M. Miglioli. 1998. Blood tests in themanagement of Helicobacter pylori infection. Italian Helicobacter pylori StudyGroup. Gut 43(Suppl. 1):S39–46.10a.van der Ende, A., R. W. van der Hulst, P. Roorda, G. N. Tytgat, and J.FIG. 1. Summary plot based on the median, quartiles, and extreme HM-CAP (A) and Immulite (B) values, obtained with the sera of 142 H. pylori-positive patientsand 32 H. pylori-negative controls. The box represents the interquartile range which contains the middle 50% of values. The whiskers extend to the highest and lowestvalues, excluding outliers. The line across the box indicates the median.VOL. 37, 1999 NOTES 4151Dankert. 1998. Evaluation of three commercial serological tests to assessHelicobacter pylori infection, abstr. V-1, p. 513. In Abstracts of the 98thGeneral Meeting of the American Society for Microbiology. American So-ciety for Microbiology, Washington, D.C.11. van der Hulst, R. W. M., E. A. J. Rauws, B. Köycü, J. J. Keller, J. G. P.Tyssen, M. Bruno, and G. N. J. Tytgat. 1997. Prevention of ulcer recurrenceafter successful eradication of Helicobacter pylori infection: a prospectivelong term follow-up study. Gastroenterology 113:1082–1086.12. van der Hulst, R. W. M., E. A. J. Rauws, B. Köycü, J. J. Keller, J. Dankert,G. N. J. Tytgat, and A. van der Ende. 1997. H. pylori reinfection is virtuallyabsent after successful eradication, analyzed by DNA-fingerprinting. J. In-fect. Dis. 176:196–200.13. Werdmuller, B. F., A. B. van der Putten, R. A. Veenendaal, C. B. Lamers, andR. J. Loffeld. 1998. Can screening for IgG antibodies against Helicobacterpylori be used in clinical practice? Omit endoscopy in seropositive or sero-negative patients? Dig. Dis. Sci. 43:2296–2300.4152 NOTES J. CLIN. MICROBIOL.

English

Evaluation of three commercial serological tests with different methodologies to assess Helicobacter pylori infection

NARCIS 

UvA-DARE

van der Hulst, R. W.

Roorda, P.

Tytgat, G. N.

UvA-DARE is a service provided by the library of the University of Amsterdam (https://dare.uva.nl)UvA-DARE (Digital Academic Repository)Evaluation of three commercial serological tests with different methodologies toassess Helicobacter pylori infectionvan der Ende, A.; van der Hulst, R.W.M.; Roorda, P.L.H.; Tytgat, G.N.J.; Dankert, J.Publication date1999Published inJournal of Clinical MicrobiologyLink to publicationCitation for published version (APA):van der Ende, A., van der Hulst, R. W. M., Roorda, P. L. H., Tytgat, G. N. J., & Dankert, J.(1999). Evaluation of three commercial serological tests with different methodologies toassess Helicobacter pylori infection. Journal of Clinical Microbiology, 37, 4150-4152.General rightsIt is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s)and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an opencontent license (like Creative Commons).Disclaimer/Complaints regulationsIf you believe that digital publication of certain material infringes any of your rights or (privacy) interests, pleaselet the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the materialinaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letterto: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. Youwill be contacted as soon as possible.Download date:11 Mar 2023JOURNAL OF CLINICAL MICROBIOLOGY,0095-1137/99/$04.0010Dec. 1999, p. 4150–4152 Vol. 37, No. 12Copyright © 1999, American Society for Microbiology. All Rights Reserved.Evaluation of Three Commercial Serological Tests with DifferentMethodologies To Assess Helicobacter pylori InfectionA. VAN DER ENDE,1* R. W. M. VAN DER HULST,2,3† P. ROORDA,1 G. N. J. TYTGAT,2 AND J. DANKERT1Department of Medical Microbiology1 and Department of Gastroenterology,2Academic Medical Center, Amsterdam, The NetherlandsReceived 19 April 1999/Returned for modification 21 August 1999/Accepted 7 September 1999The sera of 142 Helicobacter pylori-positive and 32 H. pylori-negative patients were assessed by a desktop test(QuickVue), an enzyme-linked immunosorbent assay (ELISA) (HM-CAP), and a solid-phase, two-step chemi-luminescent enzyme immunoassay (Immulite). These tests yielded sensitivities of 97, 97, and 91% and speci-ficities of 97, 94, and 100%, respectively. In conclusion, the desktop test and the ELISA are more sensitive thanthe chemiluminescent enzyme immunoassay (P < 0.05). The chemiluminescent enzyme immunoassay has theadvantage that it is fully automated.Helicobacter pylori infection in humans is one of the mostwidespread infections today, and its cure prevents peptic ulcerrecurrence (11). Besides chronic gastritis and peptic ulcer dis-ease, H. pylori infection is strongly associated with gastric can-cer and cancer of mucosa-associated lymphoid tissue (2, 3, 6)and is diagnosed by culturing of gastric biopsy specimens. Non-invasive tests like the urea breath test and tests based onserology may be an alternative for assessing H. pylori infection(1, 4, 8). Serology tests can be based on either the detection ofH. pylori antigens in the feces of patients or anti-H. pyloriantibodies in the patients’ blood or saliva (8, 9). The exact roleof serology in the management of H. pylori infection has still tobe defined, although there is evidence that, used as a screeningprocedure, it can reduce endoscopy cost and workload (10, 13).The aim of this study was to evaluate the sensitivity and spec-ificity of three commercially available serology tests, each witha different methodology to assess H. pylori infection. The desk-top test (QuickVue; Quidel, San Diego, Calif.) is a one-steptest that was originally designed to be used as a whole-bloodtest but can also be used for serum specimens. The results canbe read 10 min after the submission of the sample to the test.The HM-CAP test (Enteric Products, Inc., Stony Brook, N.Y.)is a standard enzyme-linked immunosorbent assay (ELISA).Sera are added to wells, precoated with H. pylori antigens, in a96-well microtiter plate. The test is completed, including read-ing of the results, within 1 h. This ELISA is qualitative and usescalibration sera to convert absorbance to arbitrary values. TheImmulite test (Diagnostic Products Corporation, Los Angeles,Calif.) is a solid-phase, two-step chemiluminescent enzymeimmunoassay. The solid phase, a polystyrene bead enclosedwithin a test unit, is coated with partially purified H. pyloriantigen. The diluted serum sample and a protein-based bufferare simultaneously introduced into the test unit and incubatedfor approximately 30 min with intermittent agitation. Duringthis time, H. pylori-specific immunoglobulin G (IgG) will bindto the antigen-coated bead. Unbound serum is then removedby washing by means of centrifugation. An alkaline phospha-tase-labeled anti-human IgG is introduced, and the test unit isincubated for another 30-min cycle. Again, the unbound con-jugate is removed by a centrifugal wash. Then the chemilumi-nescent substrate is added, and the test unit is incubated for afurther 10 min. The chemiluminescent substrate, a phosphateester of adamantyl dioxetane, undergoes hydrolysis in the pres-ence of alkaline phosphatase to yield an unstable intermediate.The continuous production of this intermediate results in thesustained emission of light, thus improving precision by pro-viding a window for multiple readings. The bound complex andthus also the photon output, as measured by the luminometer,are related to the presence of anti-H. pylori IgG in the sample.A qualitative result is then obtained by comparing the patientserum result to an established cutoff. This system automaticallyhandles the serum sample and reagent additions, the incuba-tion and separation steps, and measurement of the photonoutput via the temperature-controlled luminometer. Test re-sults for controls and patient samples are obtained from com-parison of the observed signal with a cutoff derived from theadjuster’s response and the bar-coded parameters. A printedreport is generated after completion of the test.(Part of this work was presented at the 98th General Meet-ing of the American Society for Microbiology [10a]).One hundred forty-two H. pylori-infected dyspeptic adults(70 with peptic ulcer disease and 72 with gastritis only) under-went gastroduodenoscopy at the Department of Gastroenter-ology in the Academic Medical Center, Amsterdam, The Neth-erlands (12). During each endoscopic procedure, three antraland three corpus mucosal biopsy specimens were obtained byuse of sterile biopsy forceps. One antrum and one corpusbiopsy specimen were placed in 2 ml of phosphate-buffered* Corresponding author. Mailing address: Department of MedicalMicrobiology, Academic Medical Center, University of Amsterdam,P.O. Box 22700, 1100 DE Amsterdam, The Netherlands. Phone: 31-20-5664862. Fax: 31-20-6979271.† Present address: Kennemer Gasthuis, Department of InternalMedicine, Gastroenterology, 2023 EA Haarlem, The Netherlands.TABLE 1. Sensitivity, specificity, and positive and negativepredictive values of three H. pylori serology testsaTest used Sensitivity SpecificityPositivepredictivevalueNegativepredictivevalueDesktop 97 (138/142) 97 (31/32) 99 (138/139) 89 (31/35)ELISA 97 (138/142) 94 (30/32) 99 (138/140) 88 (30/34)Two-step solidphase91 (129/142) 100 (32/32) 100 (129/129) 71 (32/45)a Values are shown as percentages (number of samples correctly identified/total number of samples).4150saline at 4°C and used for bacteriological culturing. The otherfour specimens were fixed in 10% formalin for histopatholog-ical examination. Cultures were prepared by smearing biopsyspecimens on the surface of horse blood agar plats (7% defi-brinated horse blood Columbia agar base; Oxoid CM 331;Unipath, Basingstoke, England) and horse blood agar platescontaining Skirrow supplement (Unipath). H. pylori organismswere identified on the basis of typical colony morphology;characteristic appearance on Gram staining; and positive ure-ase, oxidase, and catalase tests. H. pylori infection was presentif either culture and histopathological assessment or only his-topathology assessment was positive. Controls were 32 nonin-fected patients. They had H. pylori-negative cultures and nor-mal histopathology of multiple gastric biopsy specimens for atleast 4 years prior to serological testing. Blood was drawn fromthe H. pylori-positive patients and from the H. pylori-negativecontrols by venous puncture. After clotting, serum was storedat 270°C in small aliquots. Sera were assessed by the threedifferent serology tests according to the manufacturers’ proto-cols. The results obtained with the three different tests with thesera from 142 H. pylori-positive patients and 32 H. pylori-neg-ative patients are presented in Table 1. The sensitivities of theQuickVue, the HM-CAP, and the Immulite tests were 97, 97,and 91%, respectively (Table 1) (P , 0.05). The three tests hadspecificities of 97, 94, and 100%, respectively (not significant).The positive predictive values of the three tests were 99, 99,and 100%, respectively. The negative predictive values of thetests were 89, 88, and 71%, respectively (differences not sig-nificant). The sensitivity values of the ELISA and the desktoptest were in the same range as those reported by others (4, 5).The specificity of the tests in this study was somewhat higher.This may be explained by the H. pylori-negative controls in-cluded in this study. The subjects in this group were H. pylorinegative by culture and histopathology over a prolonged pe-riod of at least 4 years. This significantly diminishes the chanceof finding serological false positives in this group, because theconcentration of anti-H. pylori antibodies, elicited by a pos-sible infection prior to the H. pylori-negative period, wouldbe strongly reduced during that H. pylori-negative period.The desktop test is designed to be used as a whole-blood testand awaits evaluation as such, especially in a primary caresetting. In contrast to the QuickVue test, the HM-CAP andImmulite tests provide quantitative data (Fig. 1). The dy-namic range of the Immulite test is wider than that of theHM-CAP test, which may be beneficial for posttreatmentevaluation.In conclusion, the three serology tests are sensitive and spe-cific tests to assess H. pylori infection. The desktop test and theELISA are more sensitive than the chemiluminescent enzymeimmunoassay, but the QuickVue desktop test provides onlyqualitative results. However, the desktop test has the advan-tage of obtaining results within minutes. The ELISA HM-CAPand the chemiluminescent enzyme immunoassay Immulite areboth quantitative, but the latter test has the advantage thatsample handling, reading, and interpretation are fully auto-mated. The design of the Immulite test, i.e., accurate quanti-fication by using internal controls and a wide dynamic range inoutput values, makes it potentially suitable to assess H. pylorieradication by comparison of the patient’s pretreatment serumwith the posttreatment serum.REFERENCES1. Bazzoli, F., M. Zagari, S. Fossi, P. Pozzato, L. Ricciardiello, C. Mwangemi,A. Roda, and E. Roda. 1997. Urea breath tests for the detection of Helico-bacter pylori infection. Helicobacter 2(Suppl. 1):S34–S37.2. Blaser, M. J., G. I. Perez-Perez, and H. Kleanthous. 1995. Infection withHelicobacter pylori strains possessing cagA associated with an increasedrisk of developing adenocarcinoma of the stomach. Cancer Res. 55:2111–2115.3. Foreman, D., and the Eurogast Study Group. 1993. An international asso-ciation between Helicobacter pylori infection and gastric cancer. Lancet 341:359–362.4. Laheij, R. J. F., H. Straatman, J. B. M. J. Jansen, and A. L. M. Verbeek.1998. Evaluation of commercially available Helicobacter pylori kits: a review.J. Clin. Microbiol. 36:2803–2809.5. Meijer, B. C., J. C. Thijs, J. H. Kleibeuker, A. A. van Zwet, and R. J.Berrelkamp. 1997. Evaluation of eight enzyme immunoassays for detectionof immunoglobulin G against Helicobacter pylori. J. Clin. Microbiol. 35:292–294.6. Parsonnet, J., S. Hansen, L. Rodriguez, A. B. Gelb, R. A. Warnke, E. Jellum,N. Orentreich, J. H. Vogelman, and G. D. Friedman. 1994. Helicobacter pyloriinfection and gastric lymphoma. N. Engl. J. Med. 330:1267–1271.7. Savarino, V., S. Vigneri, and G. Celle. 1999. The 13C urea breath test in thediagnosis of Helicobacter pylori. Gut 45(Suppl. 1):118–122.8. Vaira, D., J. Holton, M. Menegatti, C. Ricci, F. Landi, A. Ali’, L. Gatta, C.Acciardi, S. Farinelli, M. Crosatti, S. Berardi, and M. Miglioli. 1999. Newimmunological assays for the diagnosis of Helicobacter pylori infection. Gut45(Suppl. 1):123–127.9. Vaira, D., P. Malfertheiner, F. Megraud, A. T. Axon, M. Deltenre, A. M.Hirschl, G. Gasbarrini, C. O’Morain, J. M. Garcia, M. Quina, and G. N.Tytgat. 1999. Diagnosis of Helicobacter pylori infection with a new non-invasive antigen-based assay. HpSA European study group. Lancet 354:30–33.10. Vaira, D., J. Holton, M. Menegatti, F. Landi, C. Ricci, A. Ali’, L. Gatta, S.Farinelli, C. Acciardi, M. Massardi, and M. Miglioli. 1998. Blood tests in themanagement of Helicobacter pylori infection. Italian Helicobacter pylori StudyGroup. Gut 43(Suppl. 1):S39–46.10a.van der Ende, A., R. W. van der Hulst, P. Roorda, G. N. Tytgat, and J.FIG. 1. Summary plot based on the median, quartiles, and extreme HM-CAP (A) and Immulite (B) values, obtained with the sera of 142 H. pylori-positive patientsand 32 H. pylori-negative controls. The box represents the interquartile range which contains the middle 50% of values. The whiskers extend to the highest and lowestvalues, excluding outliers. The line across the box indicates the median.VOL. 37, 1999 NOTES 4151Dankert. 1998. Evaluation of three commercial serological tests to assessHelicobacter pylori infection, abstr. V-1, p. 513. In Abstracts of the 98thGeneral Meeting of the American Society for Microbiology. American So-ciety for Microbiology, Washington, D.C.11. van der Hulst, R. W. M., E. A. J. Rauws, B. Köycü, J. J. Keller, J. G. P.Tyssen, M. Bruno, and G. N. J. Tytgat. 1997. Prevention of ulcer recurrenceafter successful eradication of Helicobacter pylori infection: a prospectivelong term follow-up study. Gastroenterology 113:1082–1086.12. van der Hulst, R. W. M., E. A. J. Rauws, B. Köycü, J. J. Keller, J. Dankert,G. N. J. Tytgat, and A. van der Ende. 1997. 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Evaluation of three commercial serological tests with different methodologies to assess Helicobacter pylori infection

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