A clinical validation study conducted at Oulu University Hospital (OUH) has confirmed the high accuracy of a new test for the diagnosis of atrophic gastritis (AG) and Helicobacter pylori (Hp) infection in patients referred for gastroscopy.
Biohit Oyj’s new generation GastroPanel blood test is designed for the first-line diagnosis of Hp infection and AG in patients with upper abdominal symptoms, such as dyspepsia and gastro-oesophageal reflux disease (GORD), before endoscopy. It is also capable of monitoring the regulatory mechanism of acid output in the stomach.
Hp infection, AG and high acid output are important risk factors for gastric and oesophageal cancers. The new generation (unified) GastroPanel test works on the same principle as the original GastroPanel ELISA test and is designed to harmonise the ELISA processing conditions of four biomarkers. This assay is therefore a cost-effective solution for population-based screening for the risk of gastric cancer in asymptomatic and symptomatic individuals, and its efficacy has already been confirmed by several studies in both high- and low-risk countries.
This latest study1 evaluated the diagnostic accuracy of the new generation test for the diagnosis of both AG and Hp infection in patients referred for gastroscopy from Primary Care with different indications. Along with the previously published clinical validation studies,2,3 this biopsy-confirmed study was designed to verify the diagnostic capabilities of the new generation GastroPanel test compared to the current gold standard (gastroscopy and biopsy analysis), and to demonstrate its performance was comparable to the original GastroPanel test. The positive results from this study also pave the way for Biohit’s new GastroPanel Quick Test (point of care test) which will be launched in Q1 2022.
Dr. Olli-Pekka Koivurova, principal investigator of the study at OUH, commented: “A total of 522 patients referred for gastroscopy at the Gastro Centre, OUH, were consented and enrolled for this particular study. Blood was sampled for all patients using the GastroPanel test, along with performing quality-controlled gastroscopies with mucosal biopsies. The results confirmed that the new generation GastroPanel is a highly accurate test for the non-invasive diagnosis of AG and Hp infection in patients referred for diagnostic gastroscopies.”
References
1. Koivurova O-P, et al. Serological biomarker panel in diagnosis of atrophic gastritis and Helicobacter pylori infection in gastroscopy referral patients. Clinical validation of the new generation GastroPanel® test. Anticancer Res. 2021, 41, 5527-5537.
2. Koivurova O-P, et al. Screening of the patients with autoimmune thyroid disease (AITD) and type 1 diabetes mellitus (DM1) for atrophic gastritis (AG) by serological biomarker testing (GastroPanel®). EC Gastroenterol. Digest. Syst, 2020, 7, 181-195.
3. Mäki M, et al. Helicobacter pylori (Hp) IgG ELISA of the new-generation GastroPanel® is highly accurate in diagnosis of Hp-Infection in gastroscopy referral patients. Anticancer Res, 2020, 40, 6387-6398.
