Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test
Background. Antigens derived from Helicobacter pylori can be used as stool biomarkers to assist in the diagnosis of H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori SA chemiluminescent immunoassay a...
Gespeichert in:
| Veröffentlicht in: | BioMed research international 2020, Vol.2020 (2020), p.1-6 |
|---|---|
| Hauptverfasser: | , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 6 |
|---|---|
| container_issue | 2020 |
| container_start_page | 1 |
| container_title | BioMed research international |
| container_volume | 2020 |
| creator | Sutton, Fred M. Saracino, Ilaria Maria Fiorini, Giulia Blocki, Frank A. Rode, Ashli Zierold, Claudia Opekun, Antone R. Vaira, Dino |
| description | Background. Antigens derived from Helicobacter pylori can be used as stool biomarkers to assist in the diagnosis of H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori SA chemiluminescent immunoassay against more invasive biopsy tests that are considered to be the “gold standard” (Composite Reference Method). Methods. This prospective multisite study enrolled patients undergoing an esophagogastroduodenoscopy with collection of biopsy and stool specimens. Adult patients (≥22 years) participated in the study from February 2017 to August 2018. Specimens of the stomach were tested by three methods, known as the Composite Reference Method: (1) histological evaluation, (2) culture of the organism, and (3) rapid urease detection test. H. pylori in stool was detected using the automated LIAISON® Meridian H. pylori SA assay, a chemiluminescent immunoassay. Statistical analyses were performed using MedCalc 18.11.6. Results. 277 patients (63% female) were included in the study. The prevalence of infected subjects was 24.2% in this study cohort. Clinical performance assessed against the Composite Reference Method showed very good agreement (Cohen’s kappa=0.922), with good sensitivity (95.5%) and specificity (97.6%). Reproducibility study results showed total imprecision ranging from 3.1% to 13.9% CV. Conclusion. The automated LIAISON® Meridian H. pylori SA assay brings reliable noninvasive testing for H. pylori to the laboratory that is in very good agreement with the current, more invasive biopsy-based methods such as histology, culture, or rapid urease test. The clinical trial identifiers are NCT03060746 (pretherapy) and NCT03060733 (posttherapy). |
| doi_str_mv | 10.1155/2020/7189519 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7114771</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A624689360</galeid><sourcerecordid>A624689360</sourcerecordid><originalsourceid>FETCH-LOGICAL-c565t-85161e715899a6d01b4a395bacf48909fa001b7c904638fc37e206c4414b79c13</originalsourceid><addsrcrecordid>eNqN0UFrFDEUB_Agii21N88S8CLotnmTTCa5CMOidmG1wlbwFrKZZDdlJtlmZpR-KT-En8wMu27Vk7kkJD_-eY-H0HMgFwBleVmQglxWIGQJ8hE6LSiwGQcGj49nSk_Qed_fkrwEcCL5U3RCi0IQLsUp-jpvffBGt_izTS6mTgdjcXR42Fpcj0Ps9GAbvFzUi9X1p58_8EebfON1wFcXeHffxuTxqsarIcYW12HwGxvwje2HZ-iJ021vzw_7Gfry_t3N_Gq2vP6wmNfLmSl5OcxECRxsBaWQUvOGwJppKsu1No4JSaTTJN9VRhLGqXCGVrYg3DAGbF1JA_QMvd3n7sZ1Zxtjw5B0q3bJdzrdq6i9-vsl-K3axG-qAmBVNQW8OgSkeDfmylXne2PbVgcbx14VVMgiWygzffkPvY1jCrm9STGgTArxoDa6tcoHF_O_ZgpVNS8YF5JyktWbvTIp9n2y7lgyEDXNVk2zVYfZZv7izzaP-PckM3i9B1sfGv3d_2eczcY6_aCBck4Z_QUAB7JH</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2384134988</pqid></control><display><type>article</type><title>Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test</title><source>MEDLINE</source><source>PubMed Central Open Access</source><source>Wiley-Blackwell Open Access Titles</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Sutton, Fred M. ; Saracino, Ilaria Maria ; Fiorini, Giulia ; Blocki, Frank A. ; Rode, Ashli ; Zierold, Claudia ; Opekun, Antone R. ; Vaira, Dino</creator><contributor>Kahaleh, Michel ; Michel Kahaleh</contributor><creatorcontrib>Sutton, Fred M. ; Saracino, Ilaria Maria ; Fiorini, Giulia ; Blocki, Frank A. ; Rode, Ashli ; Zierold, Claudia ; Opekun, Antone R. ; Vaira, Dino ; Kahaleh, Michel ; Michel Kahaleh</creatorcontrib><description>Background. Antigens derived from Helicobacter pylori can be used as stool biomarkers to assist in the diagnosis of H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori SA chemiluminescent immunoassay against more invasive biopsy tests that are considered to be the “gold standard” (Composite Reference Method). Methods. This prospective multisite study enrolled patients undergoing an esophagogastroduodenoscopy with collection of biopsy and stool specimens. Adult patients (≥22 years) participated in the study from February 2017 to August 2018. Specimens of the stomach were tested by three methods, known as the Composite Reference Method: (1) histological evaluation, (2) culture of the organism, and (3) rapid urease detection test. H. pylori in stool was detected using the automated LIAISON® Meridian H. pylori SA assay, a chemiluminescent immunoassay. Statistical analyses were performed using MedCalc 18.11.6. Results. 277 patients (63% female) were included in the study. The prevalence of infected subjects was 24.2% in this study cohort. Clinical performance assessed against the Composite Reference Method showed very good agreement (Cohen’s kappa=0.922), with good sensitivity (95.5%) and specificity (97.6%). Reproducibility study results showed total imprecision ranging from 3.1% to 13.9% CV. Conclusion. The automated LIAISON® Meridian H. pylori SA assay brings reliable noninvasive testing for H. pylori to the laboratory that is in very good agreement with the current, more invasive biopsy-based methods such as histology, culture, or rapid urease test. The clinical trial identifiers are NCT03060746 (pretherapy) and NCT03060733 (posttherapy).</description><identifier>ISSN: 2314-6133</identifier><identifier>EISSN: 2314-6141</identifier><identifier>DOI: 10.1155/2020/7189519</identifier><identifier>PMID: 32280698</identifier><language>eng</language><publisher>Cairo, Egypt: Hindawi Publishing Corporation</publisher><subject>Accuracy ; Adult ; Aged ; Antibiotics ; Antigens ; Antigens, Bacterial - analysis ; Automation ; Biomarkers ; Biopsy ; Chemiluminescence ; Clinical Study ; Clinical trials ; Disease ; Endoscopy ; Enrollments ; Feces - microbiology ; Female ; Gastric cancer ; Health aspects ; Helicobacter infections ; Helicobacter Infections - diagnosis ; Helicobacter Infections - immunology ; Helicobacter pylori ; Helicobacter pylori - immunology ; Histology ; Histopathology ; Humans ; Immunoassay ; Immunoenzyme Techniques - methods ; Immunoglobulins ; Infection ; Infections ; Male ; Medical research ; Medical tests ; Medicine, Experimental ; Middle Aged ; Prospective Studies ; Reproducibility of Results ; Sensitivity and Specificity ; Statistical analysis ; Urease ; Young Adult</subject><ispartof>BioMed research international, 2020, Vol.2020 (2020), p.1-6</ispartof><rights>Copyright © 2020 Antone R. Opekun et al.</rights><rights>COPYRIGHT 2020 John Wiley & Sons, Inc.</rights><rights>Copyright © 2020 Antone R. Opekun et al. This is an open access article distributed under the Creative Commons Attribution License (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. http://creativecommons.org/licenses/by/4.0</rights><rights>Copyright © 2020 Antone R. Opekun et al. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c565t-85161e715899a6d01b4a395bacf48909fa001b7c904638fc37e206c4414b79c13</citedby><cites>FETCH-LOGICAL-c565t-85161e715899a6d01b4a395bacf48909fa001b7c904638fc37e206c4414b79c13</cites><orcidid>0000-0002-7898-0470 ; 0000-0003-4837-6480</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7114771/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7114771/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,4021,27921,27922,27923,53789,53791</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32280698$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Kahaleh, Michel</contributor><contributor>Michel Kahaleh</contributor><creatorcontrib>Sutton, Fred M.</creatorcontrib><creatorcontrib>Saracino, Ilaria Maria</creatorcontrib><creatorcontrib>Fiorini, Giulia</creatorcontrib><creatorcontrib>Blocki, Frank A.</creatorcontrib><creatorcontrib>Rode, Ashli</creatorcontrib><creatorcontrib>Zierold, Claudia</creatorcontrib><creatorcontrib>Opekun, Antone R.</creatorcontrib><creatorcontrib>Vaira, Dino</creatorcontrib><title>Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test</title><title>BioMed research international</title><addtitle>Biomed Res Int</addtitle><description>Background. Antigens derived from Helicobacter pylori can be used as stool biomarkers to assist in the diagnosis of H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori SA chemiluminescent immunoassay against more invasive biopsy tests that are considered to be the “gold standard” (Composite Reference Method). Methods. This prospective multisite study enrolled patients undergoing an esophagogastroduodenoscopy with collection of biopsy and stool specimens. Adult patients (≥22 years) participated in the study from February 2017 to August 2018. Specimens of the stomach were tested by three methods, known as the Composite Reference Method: (1) histological evaluation, (2) culture of the organism, and (3) rapid urease detection test. H. pylori in stool was detected using the automated LIAISON® Meridian H. pylori SA assay, a chemiluminescent immunoassay. Statistical analyses were performed using MedCalc 18.11.6. Results. 277 patients (63% female) were included in the study. The prevalence of infected subjects was 24.2% in this study cohort. Clinical performance assessed against the Composite Reference Method showed very good agreement (Cohen’s kappa=0.922), with good sensitivity (95.5%) and specificity (97.6%). Reproducibility study results showed total imprecision ranging from 3.1% to 13.9% CV. Conclusion. The automated LIAISON® Meridian H. pylori SA assay brings reliable noninvasive testing for H. pylori to the laboratory that is in very good agreement with the current, more invasive biopsy-based methods such as histology, culture, or rapid urease test. The clinical trial identifiers are NCT03060746 (pretherapy) and NCT03060733 (posttherapy).</description><subject>Accuracy</subject><subject>Adult</subject><subject>Aged</subject><subject>Antibiotics</subject><subject>Antigens</subject><subject>Antigens, Bacterial - analysis</subject><subject>Automation</subject><subject>Biomarkers</subject><subject>Biopsy</subject><subject>Chemiluminescence</subject><subject>Clinical Study</subject><subject>Clinical trials</subject><subject>Disease</subject><subject>Endoscopy</subject><subject>Enrollments</subject><subject>Feces - microbiology</subject><subject>Female</subject><subject>Gastric cancer</subject><subject>Health aspects</subject><subject>Helicobacter infections</subject><subject>Helicobacter Infections - diagnosis</subject><subject>Helicobacter Infections - immunology</subject><subject>Helicobacter pylori</subject><subject>Helicobacter pylori - immunology</subject><subject>Histology</subject><subject>Histopathology</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Immunoenzyme Techniques - methods</subject><subject>Immunoglobulins</subject><subject>Infection</subject><subject>Infections</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical tests</subject><subject>Medicine, Experimental</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>Statistical analysis</subject><subject>Urease</subject><subject>Young Adult</subject><issn>2314-6133</issn><issn>2314-6141</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>RHX</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqN0UFrFDEUB_Agii21N88S8CLotnmTTCa5CMOidmG1wlbwFrKZZDdlJtlmZpR-KT-En8wMu27Vk7kkJD_-eY-H0HMgFwBleVmQglxWIGQJ8hE6LSiwGQcGj49nSk_Qed_fkrwEcCL5U3RCi0IQLsUp-jpvffBGt_izTS6mTgdjcXR42Fpcj0Ps9GAbvFzUi9X1p58_8EebfON1wFcXeHffxuTxqsarIcYW12HwGxvwje2HZ-iJ021vzw_7Gfry_t3N_Gq2vP6wmNfLmSl5OcxECRxsBaWQUvOGwJppKsu1No4JSaTTJN9VRhLGqXCGVrYg3DAGbF1JA_QMvd3n7sZ1Zxtjw5B0q3bJdzrdq6i9-vsl-K3axG-qAmBVNQW8OgSkeDfmylXne2PbVgcbx14VVMgiWygzffkPvY1jCrm9STGgTArxoDa6tcoHF_O_ZgpVNS8YF5JyktWbvTIp9n2y7lgyEDXNVk2zVYfZZv7izzaP-PckM3i9B1sfGv3d_2eczcY6_aCBck4Z_QUAB7JH</recordid><startdate>2020</startdate><enddate>2020</enddate><creator>Sutton, Fred M.</creator><creator>Saracino, Ilaria Maria</creator><creator>Fiorini, Giulia</creator><creator>Blocki, Frank A.</creator><creator>Rode, Ashli</creator><creator>Zierold, Claudia</creator><creator>Opekun, Antone R.</creator><creator>Vaira, Dino</creator><general>Hindawi Publishing Corporation</general><general>Hindawi</general><general>John Wiley & Sons, Inc</general><general>Hindawi Limited</general><scope>ADJCN</scope><scope>AHFXO</scope><scope>RHU</scope><scope>RHW</scope><scope>RHX</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7QO</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>CWDGH</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-7898-0470</orcidid><orcidid>https://orcid.org/0000-0003-4837-6480</orcidid></search><sort><creationdate>2020</creationdate><title>Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test</title><author>Sutton, Fred M. ; Saracino, Ilaria Maria ; Fiorini, Giulia ; Blocki, Frank A. ; Rode, Ashli ; Zierold, Claudia ; Opekun, Antone R. ; Vaira, Dino</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c565t-85161e715899a6d01b4a395bacf48909fa001b7c904638fc37e206c4414b79c13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Accuracy</topic><topic>Adult</topic><topic>Aged</topic><topic>Antibiotics</topic><topic>Antigens</topic><topic>Antigens, Bacterial - analysis</topic><topic>Automation</topic><topic>Biomarkers</topic><topic>Biopsy</topic><topic>Chemiluminescence</topic><topic>Clinical Study</topic><topic>Clinical trials</topic><topic>Disease</topic><topic>Endoscopy</topic><topic>Enrollments</topic><topic>Feces - microbiology</topic><topic>Female</topic><topic>Gastric cancer</topic><topic>Health aspects</topic><topic>Helicobacter infections</topic><topic>Helicobacter Infections - diagnosis</topic><topic>Helicobacter Infections - immunology</topic><topic>Helicobacter pylori</topic><topic>Helicobacter pylori - immunology</topic><topic>Histology</topic><topic>Histopathology</topic><topic>Humans</topic><topic>Immunoassay</topic><topic>Immunoenzyme Techniques - methods</topic><topic>Immunoglobulins</topic><topic>Infection</topic><topic>Infections</topic><topic>Male</topic><topic>Medical research</topic><topic>Medical tests</topic><topic>Medicine, Experimental</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><topic>Statistical analysis</topic><topic>Urease</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sutton, Fred M.</creatorcontrib><creatorcontrib>Saracino, Ilaria Maria</creatorcontrib><creatorcontrib>Fiorini, Giulia</creatorcontrib><creatorcontrib>Blocki, Frank A.</creatorcontrib><creatorcontrib>Rode, Ashli</creatorcontrib><creatorcontrib>Zierold, Claudia</creatorcontrib><creatorcontrib>Opekun, Antone R.</creatorcontrib><creatorcontrib>Vaira, Dino</creatorcontrib><collection>الدوريات العلمية والإحصائية - e-Marefa Academic and Statistical Periodicals</collection><collection>معرفة - المحتوى العربي الأكاديمي المتكامل - e-Marefa Academic Complete</collection><collection>Hindawi Publishing Complete</collection><collection>Hindawi Publishing Subscription Journals</collection><collection>Hindawi Publishing Open Access Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Middle East & Africa Database</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BioMed research international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sutton, Fred M.</au><au>Saracino, Ilaria Maria</au><au>Fiorini, Giulia</au><au>Blocki, Frank A.</au><au>Rode, Ashli</au><au>Zierold, Claudia</au><au>Opekun, Antone R.</au><au>Vaira, Dino</au><au>Kahaleh, Michel</au><au>Michel Kahaleh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test</atitle><jtitle>BioMed research international</jtitle><addtitle>Biomed Res Int</addtitle><date>2020</date><risdate>2020</risdate><volume>2020</volume><issue>2020</issue><spage>1</spage><epage>6</epage><pages>1-6</pages><issn>2314-6133</issn><eissn>2314-6141</eissn><abstract>Background. Antigens derived from Helicobacter pylori can be used as stool biomarkers to assist in the diagnosis of H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori SA chemiluminescent immunoassay against more invasive biopsy tests that are considered to be the “gold standard” (Composite Reference Method). Methods. This prospective multisite study enrolled patients undergoing an esophagogastroduodenoscopy with collection of biopsy and stool specimens. Adult patients (≥22 years) participated in the study from February 2017 to August 2018. Specimens of the stomach were tested by three methods, known as the Composite Reference Method: (1) histological evaluation, (2) culture of the organism, and (3) rapid urease detection test. H. pylori in stool was detected using the automated LIAISON® Meridian H. pylori SA assay, a chemiluminescent immunoassay. Statistical analyses were performed using MedCalc 18.11.6. Results. 277 patients (63% female) were included in the study. The prevalence of infected subjects was 24.2% in this study cohort. Clinical performance assessed against the Composite Reference Method showed very good agreement (Cohen’s kappa=0.922), with good sensitivity (95.5%) and specificity (97.6%). Reproducibility study results showed total imprecision ranging from 3.1% to 13.9% CV. Conclusion. The automated LIAISON® Meridian H. pylori SA assay brings reliable noninvasive testing for H. pylori to the laboratory that is in very good agreement with the current, more invasive biopsy-based methods such as histology, culture, or rapid urease test. The clinical trial identifiers are NCT03060746 (pretherapy) and NCT03060733 (posttherapy).</abstract><cop>Cairo, Egypt</cop><pub>Hindawi Publishing Corporation</pub><pmid>32280698</pmid><doi>10.1155/2020/7189519</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-7898-0470</orcidid><orcidid>https://orcid.org/0000-0003-4837-6480</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2314-6133 |
| ispartof | BioMed research international, 2020, Vol.2020 (2020), p.1-6 |
| issn | 2314-6133 2314-6141 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7114771 |
| source | MEDLINE; PubMed Central Open Access; Wiley-Blackwell Open Access Titles; PubMed Central; Alma/SFX Local Collection |
| subjects | Accuracy Adult Aged Antibiotics Antigens Antigens, Bacterial - analysis Automation Biomarkers Biopsy Chemiluminescence Clinical Study Clinical trials Disease Endoscopy Enrollments Feces - microbiology Female Gastric cancer Health aspects Helicobacter infections Helicobacter Infections - diagnosis Helicobacter Infections - immunology Helicobacter pylori Helicobacter pylori - immunology Histology Histopathology Humans Immunoassay Immunoenzyme Techniques - methods Immunoglobulins Infection Infections Male Medical research Medical tests Medicine, Experimental Middle Aged Prospective Studies Reproducibility of Results Sensitivity and Specificity Statistical analysis Urease Young Adult |
| title | Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-13T21%3A13%3A06IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Clinical%20Performance%20of%20the%20Automated%20LIAISON%C2%AE%20Meridian%20H.%20pylori%20SA%20Stool%20Antigen%20Test&rft.jtitle=BioMed%20research%20international&rft.au=Sutton,%20Fred%20M.&rft.date=2020&rft.volume=2020&rft.issue=2020&rft.spage=1&rft.epage=6&rft.pages=1-6&rft.issn=2314-6133&rft.eissn=2314-6141&rft_id=info:doi/10.1155/2020/7189519&rft_dat=%3Cgale_pubme%3EA624689360%3C/gale_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2384134988&rft_id=info:pmid/32280698&rft_galeid=A624689360&rfr_iscdi=true |