■血清胃蛋白酶原(PG)是胃粘膜萎缩性变化的良好指标。胃粘膜萎缩是胃癌的高危因素。PG血清学检测联合内镜检查有助于提高胃癌筛查水平。在这项研究中,我们建立了血清PG-I的参考范围,PG-II,并通过化学发光免疫分析(CLIA)和酶联免疫吸附测定(ELISA)对中国人群的PG-I/II比值(PGR)进行了比较。此外,在现实世界中,医生经常对不同测试平台的结果感到困惑。因此,进行了CLIA和ELISA方法的比较.
■来自中国六个地区的2904人作为中国成人消化疾病监测(2016)计划的一部分。这些人填写了问卷,自愿接受了检查,包括胃镜检查,尿素呼气试验,腹部超声检查和常规血清学检查。收集血清以测量PG(包括PG-I,PG-II和PGR)通过CLIA和ELISA。在检查中发现明显异常或缺席的参与者被排除在外。最终,747名健康个体被纳入本研究。Kolmogorov-Smirnov检验用于评估变量的分布。Kruskal-WallisH或曼-惠特尼U检验用于比较不同的性别,年龄,和地理群体。根据文件CLSI-EP28-A3建立了通过两种方法获得的PG的95%参考范围,具有性别的协变量,年龄,和区域。Spearman相关分析,线性回归分析和允许总误差(ATE)区域分析用于比较两种方法。
■总的来说,PG-I的95%参考范围,PG-II,CLIA测得的PGR为23.00-110.64ng/mL,2.50-19.13ng/mL,和3.87-13.30。同时,PG-I的参考范围,PG-II,和PCR检测为36.93-205.06ng/mL,1.65-17.96ng/mL,和7.50-33.60。发现由两个平台测量的PG-I和PG-II水平均受性别和年龄影响。CLIA测量的PGR受年龄影响,但不受性别影响,而通过ELISA测量的PGR不受年龄或性别的影响。区域因素对PG结果没有显著影响,除了通过ELISA检测的PG-I。最终,PGs的参考范围是根据年龄和性别分层确定的.此外,斯皮尔曼相关分析表明,PG-I的相关系数,PG-II,两种方法检测的PGR分别为0.899、0.887和0.777,表明这两种方法之间有很强的相关性。通过线性回归分析得到两种方法检测的PG水平的回归方程。ATE分析提供了两种方法之间一致性的直观描述,清楚地表明了他们之间糟糕的协议。
■这项研究通过严格和完整的注册标准建立了PG的参考范围。此外,结果表明,两种方法之间存在很强的线性关系,然而有明显的偏见,这对实验室解释很有价值。
UNASSIGNED: Serum pepsinogen (PG) is a good indicator of atrophic changes in the gastric mucosa. Gastric mucosal atrophy is a high-risk factor for gastric cancer. Serological testing for PG combined with endoscopy can help to improve gastric cancer screening. In this study, we established the reference ranges of serum 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). Besides, in the real world, doctors are often confused by the results of different testing platforms. Thus, a comparison of methods CLIA and ELISA was performed.
UNASSIGNED: 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. Participants who were found obvious abnormalities or absent from the examinations were excluded. Ultimately, 747 healthy individuals were enrolled in this study. The Kolmogorov-Smirnov test was used to assess the distribution of variables. The Kruskal-Wallis H or Mann-Whitney U-tests were used to compare different sex, age, and geographical groups. The 95% 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 utilized for comparing the two methods.
UNASSIGNED: On overall, the 95% reference ranges of PG-I, PG-II, and PGR measured by CLIA were 23.00-110.64 ng/mL, 2.50-19.13 ng/mL, and 3.87-13.30, respectively. Meanwhile, the reference ranges of PG-I, PG-II, and PGR measured by ELISA were 36.93-205.06 ng/mL, 1.65-17.96 ng/mL, and 7.50-33.60, respectively. Both PG-I and PG-II levels measured by the two platforms were found to be influenced by sex and age. PGR measured by CLIA was influenced by age but not by sex, while PGR measured by ELISA was not affected by either age or sex. Regional factors did not significantly impact the PG results, except for PG-I detected by ELISA. Ultimately, reference ranges for PGs were established based on age and sex stratification. Additionally, the Spearman correlation analysis revealed that the correlation coefficients for PG-I, PG-II, and PGR detected by the two methods were 0.899, 0.887, and 0.777, respectively, indicating a strong correlation between the two methods. The regression equation for the PG levels detected by two methods was obtained through linear regression analysis. The ATE analysis provided a visual depiction of the consistency between the two methods, clearly indicating the poor agreement between them.
UNASSIGNED: This study established the reference ranges of PGs by strict and intact enrollment standard. In addition, the results indicated a strong linear relationship between the two methods, yet with a clear bias, which was valuable for laboratory interpretation.