The Establishment and Validation of Reference Intervals for Serum Pepsinogens and Gastrin-17 Among Healthy Adults in Suzhou Area
Objective To establish the reference intervals of serum pepsinogen(PG)Ⅰ,PG Ⅱ and gastrin-17(G-17)in healthy adults from Suzhou area.Methods A retrospective analysis was conducted among 34-719 apparently healthy individuals in Suzhou area.The levels of PG Ⅰ,PG Ⅱ,and G-17 were detected using ELISA method,and the PG Ⅰ/PG Ⅱ ratio(PGR)was calculated.According to the CLSI C28-A3 document,all subjects were grouped according to gender and age distributions.The statistical methods were applied to evaluate whether the differences between the groups were statistically significant.The percentile method was used to calculate the 95％distribution range of PG Ⅰ,PG Ⅱ,PGR and G-17,and the reference interval was established.The difference between the established reference interval and the reference interval declared by the manufacturer was calculated to evaluate whether the newly established reference interval should be adopted.Results The levels of PG Ⅰ,PG Ⅱ,PGR,and G-17 in 34719 apparently healthy people showed skewed distributions,and the reference intervals were established using the percentile method.Spearman correlation analysis showed that PG Ⅰ,PG Ⅱ,and G-17 were significantly positively correlated with age(r values were 0.083,0.087,and 0.032,respectively,all P＜0.05),while PGR was significantly negatively correlated with age(r value was-0.037,P＜0.05).The serum levels of PG Ⅰ,PGⅡ and PGR in the male group were significantly higher than those in the female group(all P＜0.05),while serum G-17 levels were significantly lower than those in female group(P＜0.05),suggesting that reference intervals should be established according to different gender groups.There were significant differences in PG Ⅰ and PG Ⅱ levels in the same gender and age groups(P＜0.05);The PGR levels of the group aged ≥60 years were significantly different from those of the group aged 18-44 years and the group aged 45-59 years in the same gender groups(P＜0.05);There were statistically significant differences in G-17 in all female age groups,suggesting that reference intervals should be established according to different age groups(PG Ⅰ:42.87-147.30 and 41.55-133.34μg/L for males and females aged 18-44 years,43.29-153.90 and 41.86-131.34µg/L for males and females aged 45-59 years,44.48-155.28 and 42.16-139.72µg/L for males and females aged ≥60 years.PG Ⅱ:≤17.56 and ≤ 17.29 μg/L for males and females aged 18-44 years,≤17.85 and ≤18.64μg/L for males and females aged 45-59 years,≤18.90 and ≤18.85μg/L for males and females aged ≥60 years.PGR:≥4.85 and ≥4.47 for males and females aged 18-59 years,≥4.67 and ≥4.50 for males and females aged ≥60 years.Female G-17:0.6-13.96pmol/L for 18-44 years,0.6-14.14pmol/L for 45-59 years,0.63-14.12pmol/L for ≥60 years).There was no statistical significance in G-17 in all male age group,suggesting that a unified reference interval could be established(Male G-17:0.56-13.79pmol/L for 18 years).The newly established reference interval was validated through this process.Conclusion A preliminary reference interval of PG Ⅰ,PG Ⅱ,PGR and G-17 suitable for apparently healthy people in the studied region has been established,which could provide a useful reference for the future prevention,diagnosis and treatment of clinically related diseases.
万方数据
维普
