Point-of-Care Diagnosis of Atrophic Gastritis by Serological Biomarker Test (GastroPanel® Quick Test) in Gastroscopy Referral Patients in India

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Abstract

Background: Increased demand of the serological biomarker test (GastroPanel®) in non-invasive diagnosis of gastric cancer (GC) risk conditions, i.e., atrophic gastritis (AG) and Helicobacter pylori (Hp) infection, prompted the design of GastroPanel® Quick test (GPQT)(Biohit Oyj, Helsinki, Finland) for point-of-care (POC) settings. Objective: This study validated the diagnostic accuracy (DA) of GPQT in diagnosis of AG and Hp among gastroscopy referral patients. Material and Methods: Altogether, 266 patients were enrolled among the consecutive gastroscopy referrals at the Department of Gastroenterology, Fortis Hospital (Mohali Chandigarh, India). All patients underwent gastroscopy with biopsies (n=249) classified using the Updated Sydney System (USS) and finger prick blood sampling for GPQT testing. Results: Biopsy-confirmed AG was found in 15.3% (38/249) of the patients. The overall agreement between the GPQT and the USS classification was 71.4% (95%CI 65.4-77.0%), with the weighted kappa (w) of 0.823 (95%CI 0.773-0.862). In ROC analysis for moderate/severe AG of the corpus (AGC) endpoint, AUC=0.990 (95%CI 0.979-1.000) and AUC=0.971 (95%CI 0.948-0.995) for PGI and PGI/PGII, respectively. Hp IgG Ab test detected biopsy-confirmed Hp with AUC=0.836 (95%CI 0.783-0.889). Conclusions: The accuracy of GPQT favourably competes with the ELISA test version (unified-GP) in diagnosis of AG and Hp in patients referred for diagnostic gastroscopy.

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