流式荧光法检测胃蛋白酶原在临床的应用
发布时间：2019-01-05 18:03
【摘要】：目的:评价流式荧光法在血清胃蛋白酶原(PG)I/II检测中的临床应用价值。方法:1.评价流式荧光法检测PGI/II的精密度。2.通过检测临床血清样本与芬兰Biohit集团的Elisa试剂盒进行方法学比对。3.评价流式荧光法检测PGI/II的检测限。4.验证流式荧光法检测PGI/II的线性范围。5.应用流式荧光法检测浅表性胃炎、萎缩性胃炎、胃癌患者的血清标本。6.以PGI70、PGR3为诊断临界值,来评价血清PG诊断胃癌的敏感性和特异性。结果:1.PGI检测批内变异系数(CV)为4.26~5.35%,批间CV为6.73~7.75%。PGII检测批内CV为5.48~6.42%,批间CV为8.46~8.85%。2.与ELISA方法进行方法学比对存在线性关系,线性方程分别为PGI:Y=0.911X-22.635,R=0.966;PGII:Y=0.892X-0.548,R=0.980。3.PGI的最低检测限为0.87 ng/ml,PGII的最低检测限为0.46 ng/ml。4.PGI、PGII在试剂盒提供的线性范围内具有良好的线性(R0.99)。5.萎缩性胃炎和胃癌患者血清PGI浓度和PGI/PGII比值,明显低于浅表性胃炎组,差异有统计学意义(P.0.05)。6.以PGI70ng/ml且PGR3为诊断界值,筛查胃癌的敏感性为42.1%,特异性为95.6%结论:1.流式荧光法可以实现PGI、PGII的并行测试,方法学性能良好,操作简便,可以满足临床实验室的需求。2.流式荧光法对血清PGI和PGII的测定可以为胃癌和萎缩性胃炎的筛查及诊断提供实验室依据。
[Abstract]:Objective: to evaluate the clinical value of flow-flow fluorescence assay in the detection of serum pepsinogen (PG) I/II. Methods: 1. To evaluate the precision of flow fluorescence assay for the detection of PGI/II. 2. 2. The clinical serum samples were compared with the Elisa kit of Finland Biohit Group. 3. 3. To evaluate the detection limit of PGI/II by flow fluorescence method. 4. 4. To verify the linear range of PGI/II detection by flow fluorescence method. 5. 5. Serum samples of patients with superficial gastritis, atrophic gastritis and gastric cancer were detected by flow cytometry. The sensitivity and specificity of serum PG in the diagnosis of gastric cancer were evaluated by using PGI70,PGR3 as the diagnostic threshold. Results: the coefficient of variation (CV) of 1.PGI was 4.2655.35, that of inter-assay CV was 5.48 ~ 6.42, that of 6.73~7.75%.PGII was 5.48 ~ 6.42, and that of between-assay CV was 8.46 ~ 8.85. There is a linear relationship between the method and the ELISA method. The linear equation is PGI:Y=0.911X-22.635,R=0.966;, respectively. The minimum detection limit of PGII:Y=0.892X-0.548,R=0.980.3.PGI is 0. 87 ng/ml,PGII. The minimum detection limit is 0. 46 ng/ml.4.PGI,. PGII has a good linearity in the linear range provided by the kit (R0.99). The serum PGI concentration and PGI/PGII ratio in patients with atrophic gastritis and gastric cancer were significantly lower than those in patients with superficial gastritis (P. 0. 05). With PGI70ng/ml and PGR3 as diagnostic threshold, the sensitivity and specificity of screening gastric cancer were 42.1% and 95.6% respectively. The flow fluorescence method can realize the parallel test of PGI,PGII. The method has good performance and is easy to operate, and it can meet the needs of clinical laboratory. 2. 2. The determination of serum PGI and PGII by flow fluorescence can provide laboratory basis for screening and diagnosis of gastric cancer and atrophic gastritis.
【学位授予单位】：石河子大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R446.6
本文编号：2402118
[Abstract]:Objective: to evaluate the clinical value of flow-flow fluorescence assay in the detection of serum pepsinogen (PG) I/II. Methods: 1. To evaluate the precision of flow fluorescence assay for the detection of PGI/II. 2. 2. The clinical serum samples were compared with the Elisa kit of Finland Biohit Group. 3. 3. To evaluate the detection limit of PGI/II by flow fluorescence method. 4. 4. To verify the linear range of PGI/II detection by flow fluorescence method. 5. 5. Serum samples of patients with superficial gastritis, atrophic gastritis and gastric cancer were detected by flow cytometry. The sensitivity and specificity of serum PG in the diagnosis of gastric cancer were evaluated by using PGI70,PGR3 as the diagnostic threshold. Results: the coefficient of variation (CV) of 1.PGI was 4.2655.35, that of inter-assay CV was 5.48 ~ 6.42, that of 6.73~7.75%.PGII was 5.48 ~ 6.42, and that of between-assay CV was 8.46 ~ 8.85. There is a linear relationship between the method and the ELISA method. The linear equation is PGI:Y=0.911X-22.635,R=0.966;, respectively. The minimum detection limit of PGII:Y=0.892X-0.548,R=0.980.3.PGI is 0. 87 ng/ml,PGII. The minimum detection limit is 0. 46 ng/ml.4.PGI,. PGII has a good linearity in the linear range provided by the kit (R0.99). The serum PGI concentration and PGI/PGII ratio in patients with atrophic gastritis and gastric cancer were significantly lower than those in patients with superficial gastritis (P. 0. 05). With PGI70ng/ml and PGR3 as diagnostic threshold, the sensitivity and specificity of screening gastric cancer were 42.1% and 95.6% respectively. The flow fluorescence method can realize the parallel test of PGI,PGII. The method has good performance and is easy to operate, and it can meet the needs of clinical laboratory. 2. 2. The determination of serum PGI and PGII by flow fluorescence can provide laboratory basis for screening and diagnosis of gastric cancer and atrophic gastritis.
【学位授予单位】：石河子大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R446.6
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，本文编号：2402118
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