Brand interchangeability of pepsinogen tests in the real-world setting after eradication of Helicobacter pylori: a community-based study.

Tsung-Hsien Chiang, Yen-Nien Chen, Yi-Ru Chen, Yu-Hua Tseng, Chun-Fu Shieh, Cheng-Ying Liu, Han-Mo Chiu, Hung Chiang, Chia-Tung Shun, Ming-Shiang Wu, Jaw-Town Lin, Yi-Chia Lee

BMC gastroenterology 2022 Feb 18

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Serum pepsinogen (PG) is recommended as a screening test for premalignant gastric lesions. However, real-world evidence demonstrating its applicability and equivalence between different test brands is limited. Mass screening began in 2018 in a high-risk Taiwanese population after eradication of Helicobacter pylori, with the first stage of two PG tests (GastroPanel®, Helsinki, Finland and LZ-Test®, Tokyo, Japan) and the second stage of endoscopy. A positive test was defined as PG-I < 30 ng/mL or PG-I/II ratio < 3 for GastroPanel® and PG-I ≤ 70 ng/mL and PG-I/II ratio ≤ 3 for LZ-Test®. Index lesions included atrophic gastritis and intestinal metaplasia. Test performance was evaluated based on the participation rate, positivity rate, referral rate, positive predictive value (PPV), and the detection rate. Among 7616 eligible participants, 5117 (67.2%) received PG tests and 284 (5.6%) tested positive. Of those who tested positive, 105 (37.0%) underwent endoscopy. Overall PPVs for atrophic gastritis and intestinal metaplasia were 12.4% and 18.9%, respectively, with detection rates of 2.5 and 3.9 per 1000, respectively. Correlations of numerical measures between tests were high and the agreements of test results were substantial. The PPVs (16.3% vs. 16.3% and 23.8% vs. 21.3%, P = 1.00 and 0.71, respectively), detection rates (2.5 vs. 2.5 and 3.7 vs. 3.3 per 1000, P = 1.00 and 0.27, respectively), and the stage distributions of gastritis were all comparable, which were confirmed by multiple regression analyses. PG testing is effective for mass screening after eradication of H. pylori. Tests from different manufacturers, even using different analytical methods and cutoff criteria, can perform equivalently. © 2022. The Author(s).

Citation

Tsung-Hsien Chiang, Yen-Nien Chen, Yi-Ru Chen, Yu-Hua Tseng, Chun-Fu Shieh, Cheng-Ying Liu, Han-Mo Chiu, Hung Chiang, Chia-Tung Shun, Ming-Shiang Wu, Jaw-Town Lin, Yi-Chia Lee. Brand interchangeability of pepsinogen tests in the real-world setting after eradication of Helicobacter pylori: a community-based study. BMC gastroenterology. 2022 Feb 18;22(1):69