Reference Ranges of Serum Pepsinogens on Two Platforms in the Chinese Population

Abstract Objective The objective of this study was to establish the reference ranges of serum pepsinogen-I (PG-I), PG-II, and the PG-I/II ratio (PGR) in the Chinese population by chemiluminescence immunoassay (CLIA) and enzyme-linked immunosorbent assay (ELISA) and to explore the consistency between the two methods. Methods 2904 individuals were enrolled from six regions in China as part of the Chinese Adult Digestive Diseases Surveillance (2016) program. The individuals completed questionnaires and volunteered to undergo examinations, including gastroscopy, urea breath test, abdominal ultrasound examination and routine serologic tests. Serum was collected to measure PGs (including PG-I, PG-II and PGR) by CLIA and ELISA. The reference ranges of PGs obtained by the two methods were established according to document CLSI-EP28-A3, with covariates of sex, age, and region. Spearman correlation analysis, linear regression analysis and allowable total error (ATE) zone analysis were used to assess the consistency between the two methods. Results Participants who were found obvious abnormalities or absent from the examinations were excluded. Ultimately, 747 healthy individuals were enrolled in this study. Data from the 747 individuals were analyzed for PGs reference ranges. Reference ranges of PGs by CLIA and ELISA platforms were obtained with stratification by age group and sex. The region was not an influencing factor on the PGs results, except in the PG-I findings by ELISA. ATE zone analysis showed the consistency between the two methods was poor, and the two methods could not be substituted for each other. Conclusion This study established and compared the reference ranges of PGs on two platforms by strict and intact enrollment standard. The findings are valuable for clinical application and laboratory interpretation.