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- Title
Brand interchangeability of pepsinogen tests in the real-world setting after eradication of Helicobacter pylori: a community-based study.
- Authors
Chiang, Tsung-Hsien; Chen, Yen-Nien; Chen, Yi-Ru; Tseng, Yu-Hua; Shieh, Chun-Fu; Liu, Cheng-Ying; Chiu, Han-Mo; Chiang, Hung; Shun, Chia-Tung; Wu, Ming-Shiang; Lin, Jaw-Town; Lee, Yi-Chia
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
HELSINKI (Finland); HELICOBACTER pylori; PEPSINOGEN; ATROPHIC gastritis; MULTIPLE regression analysis; PRECANCEROUS conditions; HELICOBACTER disease diagnosis; STOMACH tumors; GASTRITIS; ENZYMES; RESEARCH funding; HELICOBACTER diseases
- Publication
BMC Gastroenterology, 2022, Vol 22, Issue 1, p1
- ISSN
1471-230X
- Publication type
journal article
- DOI
10.1186/s12876-022-02155-7