Helicobacter pylori(Hp) IgG ELISA of the New-Generation GastroPanel® Is Highly Accurate in Diagnosis of Hp-Infection in Gastroscopy Referral Patients

What Is New in Helicobacter pylori Diagnosis. An Overview

“…The GastroPanel ® , especially the new-generation test, which assesses H. pylori antibodies and pepsinogen (PG) I plus PG II and gastrin-17 in the plasma simultaneously, is able to predict H. pylori infection and the presence of atrophic gastritis with a likelihood of 94–95% [ 110 ]. The test was reported by several authors as the most comprehensive non-invasive diagnostic test, as it avoids false and negative results, with respect to conventional tests [ 57 , 110 , 111 , 112 , 113 ]. For example, in a study performed in Korea, a decreased PG I/II ratio was significantly associated with chronic atrophic gastritis and intestinal metaplasia ( p < 0.001) and, inversely, an increased ratio correlated with endoscopic findings, such as gastric and duodenal ulcer or nodular gastritis [ 111 ].…”

“…The GastroPanel ® , especially the new-generation test, which assesses H. pylori antibodies and pepsinogen (PG) I plus PG II and gastrin-17 in the plasma simultaneously, is able to predict H. pylori infection and the presence of atrophic gastritis with a likelihood of 94-95% [110]. The test was reported by several authors as the most comprehensive non-invasive diagnostic test, as it avoids false and negative results, with respect to conventional tests [57,[110][111][112][113].…”

Serological Biomarker Test (GastroPanel®) in the Diagnosis of Functional Gastric Disorders,Helicobacter pyloriand Atrophic Gastritis in Patients Examined for Dyspeptic Symptoms

“…In both of these meta-analyses, GastroPanel ® test showed pooled sensitivity >70% and pooled specificity close to 95%, when moderate/severe AG was used as the endpoint (20,33). The recently (in 2018) introduced the newgeneration (Unified) GastroPanel ® test, especially developed ELISA-automation in mind, recently passed the clinical validation studies (34,35), confirming the outstanding clinical performance of the new test version; the indicators (sensitivity, specificity) even exceeded those calculated in the two meta-analyses (20,33).…”

“…One of the features of the GastroPanel ® test is in that the results can be interpreted by the GastroSoft ® application (17,19,20,36), classifying the biomarker profiles into five categories that have a morphological equivalent in the USS (Updated Sydney System) (37) classification of gastritis: i) normal mucosa, ii) non-atrophic (Hp) gastritis, iii) AGC, iv) AGA, and v) AG in both the antrum and corpus (14-17, 20, 21, 36, 37). In addition, GastroSoft ® distinguishes three other biomarker profiles that specify functional disorders of the stomach: 1) high acid output, 2) low acid output, and 3) effects of PPI (proton pump inhibitor) medication (34)(35)(36).…”

“…Only the "morphological" biomarker profiles can be validated in settings where gastroscopy and biopsies are used as the reference test (20,(34)(35)(36), but because of the lack of any technically/clinically feasible reference test for the three "functional" biomarker profiles, a different approach needs to be used to cast light on these functional profiles of the GastroPanel ® test. The present study is the first populationbased survey reporting the point prevalence of the eight biomarker profiles in a random sample of patients examined by this non-invasive serological assay due to dyspeptic symptoms.…”