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GastroPanel® Biomarker Assay: The Most Comprehensive Test for Helicobacter pylori Infection and Its Clinical Sequelae. A Critical Review.
Anticancer Res 2019; 39(3):1091-1104AR

Abstract

BACKGROUND/AIM

Several clinical conditions seriously hamper the diagnostic accuracy of the commonly used tests for Helicobacter pylori (Hp), 13C-urea breath test (UBT) and stool antigen test (SAT). The present communication is a critical review of the potential limitations of UBT and SAT, and describes the approach on how these can be avoided. Drawbacks of the Hp tests: False-negative results are most often due to low bacterial load in the stomach due to: i) use of proton pump inhibitor medication; ii) use of antibiotics; iii) presence of atrophic gastritis and hypoacid stomach; iv); bleeding peptic ulcer; v) gastric cancer (GC) and vi) mucosal-associated lymphatic tissue lymphoma. The UBT also gives false-positive results when urease-producing bacterial species, other than Hp colonize an acid-free stomach. Importantly, neither UBT nor SAT are capable of diagnosing atrophic gastritis, thus missing the patients at highest risk for GC. GastroPanel® (Biohit Oyj, Finland) circumvents these shortcomings with a serological test consisting of a panel of stomach-specific biomarkers: pepsinogen I, pepsinogen II, gastrin-17 and Hp antibodies. GastroPanel® is a tool for non-invasive examination of i) dyspeptic patients for exclusion or diagnosis of Hp or atrophic gastritis, also disclosing the status of gastric acid output; ii) for screening of asymptomatic individuals at risk of GC; and iii) for comprehensive diagnosis of Hp infection. GastroSoft® application integrates the biomarker profile with the patient's medical information, accurately classifying the biomarker profiles into eight diagnostic categories.

CONCLUSION

Given that Hp is the single most important risk factor of GC, the non-invasive diagnosis and screening of Hp should be based on more accurate and more comprehensive testing than UBT or SAT alone. The GastroPanel® is such test, being completely devoid of the known serious shortcomings of UBT and SAT.

Authors+Show Affiliations

Department of Clinical Research, Biohit Oyj, Helsinki, Finland kasyrja@netti.fi. Molecular Oncology Research Center, Barretos Cancer Hospital, Barretos, Brazil.Department of Surgery, Kuopio University Hospital, Kuopio, Finland.Department of Surgery, University of Tartu, Tartu, Estonia.Department of Surgery, University of Tartu, Tartu, Estonia.Patolab Oy, Espoo, Finland.Department of Clinical Research, Biohit Oyj, Helsinki, Finland.Department of Research and Development, Biohit Oyj, Helsinki, Finland.Department of Research and Development, Biohit Oyj, Helsinki, Finland.Department of Research and Development, Biohit Oyj, Helsinki, Finland.Department of Clinical Research, Biohit Oyj, Helsinki, Finland. Department of Research and Development, Biohit Oyj, Helsinki, Finland.Department of Clinical and Experimental Medicine, University of Parma, Parma, Italy.Shanghai Jiaotong University School of Medicine, Shanghai Institute of Digestive Disease, Shanghai, P.R. China.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

30842138

Citation

Syrjänen, Kari, et al. "GastroPanel® Biomarker Assay: the Most Comprehensive Test for Helicobacter Pylori Infection and Its Clinical Sequelae. a Critical Review." Anticancer Research, vol. 39, no. 3, 2019, pp. 1091-1104.
Syrjänen K, Eskelinen M, Peetsalu A, et al. GastroPanel® Biomarker Assay: The Most Comprehensive Test for Helicobacter pylori Infection and Its Clinical Sequelae. A Critical Review. Anticancer Res. 2019;39(3):1091-1104.
Syrjänen, K., Eskelinen, M., Peetsalu, A., Sillakivi, T., Sipponen, P., Härkönen, M., ... Fan, Z. P. (2019). GastroPanel® Biomarker Assay: The Most Comprehensive Test for Helicobacter pylori Infection and Its Clinical Sequelae. A Critical Review. Anticancer Research, 39(3), pp. 1091-1104. doi:10.21873/anticanres.13218.
Syrjänen K, et al. GastroPanel® Biomarker Assay: the Most Comprehensive Test for Helicobacter Pylori Infection and Its Clinical Sequelae. a Critical Review. Anticancer Res. 2019;39(3):1091-1104. PubMed PMID: 30842138.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - GastroPanel® Biomarker Assay: The Most Comprehensive Test for Helicobacter pylori Infection and Its Clinical Sequelae. A Critical Review. AU - Syrjänen,Kari, AU - Eskelinen,Matti, AU - Peetsalu,Ants, AU - Sillakivi,Toomas, AU - Sipponen,Pentti, AU - Härkönen,Matti, AU - Paloheimo,Lea, AU - Mäki,Minna, AU - Tiusanen,Tapani, AU - Suovaniemi,Osmo, AU - DiMARIO,Francesco, AU - Fan,Zhu Ping, PY - 2018/12/13/received PY - 2019/01/27/revised PY - 2019/01/28/accepted PY - 2019/3/8/entrez PY - 2019/3/8/pubmed PY - 2019/3/12/medline KW - 13C-urea breath test KW - GastroPanel® KW - GastroSoft® KW - Helicobacter pylori KW - acid output KW - atrophic gastritis KW - diagnosis KW - diagnostic errors KW - false-negative KW - false-positive KW - gastric cancer KW - gastrin-17 KW - limitations KW - pepsinogen I KW - pepsinogen II KW - review KW - risk KW - serum biomarker panel KW - stool antigen test SP - 1091 EP - 1104 JF - Anticancer research JO - Anticancer Res. VL - 39 IS - 3 N2 - BACKGROUND/AIM: Several clinical conditions seriously hamper the diagnostic accuracy of the commonly used tests for Helicobacter pylori (Hp), 13C-urea breath test (UBT) and stool antigen test (SAT). The present communication is a critical review of the potential limitations of UBT and SAT, and describes the approach on how these can be avoided. Drawbacks of the Hp tests: False-negative results are most often due to low bacterial load in the stomach due to: i) use of proton pump inhibitor medication; ii) use of antibiotics; iii) presence of atrophic gastritis and hypoacid stomach; iv); bleeding peptic ulcer; v) gastric cancer (GC) and vi) mucosal-associated lymphatic tissue lymphoma. The UBT also gives false-positive results when urease-producing bacterial species, other than Hp colonize an acid-free stomach. Importantly, neither UBT nor SAT are capable of diagnosing atrophic gastritis, thus missing the patients at highest risk for GC. GastroPanel® (Biohit Oyj, Finland) circumvents these shortcomings with a serological test consisting of a panel of stomach-specific biomarkers: pepsinogen I, pepsinogen II, gastrin-17 and Hp antibodies. GastroPanel® is a tool for non-invasive examination of i) dyspeptic patients for exclusion or diagnosis of Hp or atrophic gastritis, also disclosing the status of gastric acid output; ii) for screening of asymptomatic individuals at risk of GC; and iii) for comprehensive diagnosis of Hp infection. GastroSoft® application integrates the biomarker profile with the patient's medical information, accurately classifying the biomarker profiles into eight diagnostic categories. CONCLUSION: Given that Hp is the single most important risk factor of GC, the non-invasive diagnosis and screening of Hp should be based on more accurate and more comprehensive testing than UBT or SAT alone. The GastroPanel® is such test, being completely devoid of the known serious shortcomings of UBT and SAT. SN - 1791-7530 UR - https://www.unboundmedicine.com/medline/citation/30842138/GastroPanel®_Biomarker_Assay:_The_Most_Comprehensive_Test_for_Helicobacter_pylori_Infection_and_Its_Clinical_Sequelae__A_Critical_Review_ L2 - http://ar.iiarjournals.org/cgi/pmidlookup?view=long&pmid=30842138 DB - PRIME DP - Unbound Medicine ER -