Can GastroPanel be used as a triage tool to select patients with advanced atrophic gastritis for gastroscopy? A prospective clinical validation study.

Abstract

Objective: Gastric adenocarcinoma (GAC) is the 17th most common cancer in the UK with a 5-year survival rate of 22%. GastroPanel (Biohit Oyj; Helsinki, Finland) is an ELISA kit that measures pepsinogen I (PGI); pepsinogen II (PGII); gastrin-17 (G-17); and Helicobacter pylori IgG antibodies (Hp IgG). PGI and the PGI/PGII ratio correlate inversely with the severity of chronic atrophic gastritis (AG). The aim of this study was to assess GastroPanel performance in the identification of moderate to severe AG in dyspepsia.

Methods: In this UK, single-centre, prospective diagnostic accuracy study, 324 patients [56.8% (n=184) female; median age 57 years (range 39-92 years)] were recruited for gastroscopy with biopsy and histology according to the updated Sydney System (USS). Blood (plasma) samples were collected for GastroPanel analysis. Paired samples were obtained from 268 patients [56.3% (n=151) female; median age=57 (range 39-92 years)]. GastroPanel results were interpreted using the GastroSoft app (Biohit).

Results: Overall agreement between GastroPanel and the USS classification was 90% (95% CI=86.7 to 93.8%), with a weighted kappa (κw) of 0.828 (95% CI=0.781 to 0.865). In receiver operating characteristics (ROC) curve analysis, using moderate/severe atrophic gastritis of the corpus (AGC2+) as the endpoint, AUC=0.840 (95% CI 0.630 to 1.000) and 0.960 (95% CI 0.907 to 1.000) for PGI and the PGI/PGII ratio, respectively.

Conclusion: GastroPanel is a reliable dyspepsia triage test distinguishing patients who can be safely treated conservatively from those with moderate to severe corpus atrophic gastritis at high risk of developing GAC.