摘要
目的 验证胶乳免疫比浊法测定胃蛋白酶原Ⅰ（PGⅠ）、胃蛋白酶原Ⅱ（PGⅡ）的方法学性能.方法 采用日本荣研公司生产的胶乳免疫比浊法检测PGⅠ、PGⅡ,选用校准品和临床血清样本,验证该检测方法的正确度、精密度、线性,并与现行方法芬兰BIO-HIT进行比对,评价诊断阳性率结果.结果 免疫比浊法测定PGⅠ低（25.0μg/L）、高（200.0μg/L）浓度校准品的相对偏倚分别为0.10％、4.70％,PGⅡ低（15.0μg/L）、高（100.0μg/L）浓度校准品的相对偏倚分别为0.60％、2.70％,PGⅠ、PGⅡ检测正确度良好;PGⅠ低（11.8μg/L）、中（73.0μg/L）、高（195.1μg/L）三个浓度标本的变异系数（CV）分别为3.70％、1.60％、3.30％,PGⅡ低（8.8μg/L）、中（14.6μg/L）、高（53.1μg/L）三个浓度标本的CV分别为3.68％、1.44％、1.65％,精密度符合要求;采用校准品进行稀释回收试验,当PGⅠ线性范围在200μg/L内时,线性回归方程Y=1.0108X-0.8318（R2=0.9995）.当PGⅡ线性范围在100μg/L内时,线性回归方程Y=1.007X-0.1023（R2=0.9998）.线性均良好;收集病人及体检血清样本（n=97）,分别使用胶乳凝集免疫比浊法与芬兰BIO-HIT的ELISA法进行PGⅠ、PGⅡ检测.两种方法的总符合率为93.8％（95％CI：87.2％～97.1％）,阳性符合率76.9％,阴性符合率96.4％;对称性试验通过（P〉0.999）;Cohen＇s Kappa系数73.4％（95％CI：52.7％～94.0％）,实验方法与参考方法具有较高符合率.结论 胶乳免疫比浊法检测PGⅠ、PGⅡ,快捷、准确、方便,适用临床进行大规模筛查.
Objective To identify the methodology performance of pepsinogen Ⅰ （PG Ⅰ ） and pepsinogenⅡ （PG Ⅱ） by emulsioimmunoturbidimetry. Methods The levels of PG Ⅰ and PGⅡwith calibration and clinical serum samples were measured by emulsioimmunoturbidimetry （Eiken Chemical, Japan） according to the performance index provided by the manufacturer. The accurateness, precision and linearity range of the method were identified. The results and diagnostic yield of PG which were detected by emulsioimmunoturbidimetry were compared and estimated with BIO-HIT （Finland）. Results The relative bias of PG Ⅰ calibration in lower concentration （25.0 μ g/L） and higher concentration （200.0 μ g/L） were 0.10% and 4.70% and the relative bias of PGⅡ calibration in lower concentration （15.0 μ g/L） and higher concentration （100.0 μ g/L） were 0.60% and 2.70%. Their accurateness were well measured. The coefficient of variation （CV） of PG Ⅰ in low （11.8 μg/L）, middle （73.0μg/L） and high concentration （195.1 μ g/L） were 3.70%, 1.60% and 3.30%. The CV of PGⅡ in low （8.8μ g/L）, middle （14.6μ g/L） and high concentration （53.1 μ g/L） were 3.68%, 1.44% and 1.65%. Their precision were well measured. The diluted recovery test was detected with calibration. The equation of linear regression was Y=1.0108X-0.8318 （R2=0.9995） while the linear range of PGⅠ was less than 200μg/ L; the equation of linear regression was Y=1.007X-0.1023 （R2=0.9998） while the linear range of PG Ⅱ was less than 100 μg/L. Their linearity range were well measured. The serum of patients and health volunteers （n=97） were collected. The PG Ⅰ and PG Ⅱ levels of these serum were detected by emulsioimmunoturbidimetry （Eiken Chemical, Japan, test method） and ELISA （BIO-HIT, Finland, reference method）. The overall coincidence rate was 93.8% （95%CI： 87.2% - 97.1%）, the positive coincidence rate was 76.9% and the negative coincidence rate was 96.4%. The symmetry test was passed （P 〉 0.999）. The Cohen＇s Kappa coefficient of coincident ratio was 73.4% （95%CI： 52.7% - 94.0%） excepted by chance. The concordance was high between test method and reference method. Conclusion The emulsioimmunoturbidimetry kit was used to measure the levels of PG Ⅰ and PG Ⅱ produced by Eiken Chemical Company is shortcut, accurate and convenient. It is appropriate for large-scale screening clinical application.
作者
陈永华
许中
沈东华
张剑峰
张敏健
张莉
CHEN Yong-hua;XU Zhong;SHEN Dong-hua;ZHANG Jian-feng;ZHANG Min-jian;ZHANG Li(Department of Clinical Laboratory, East District of Suzhou Municipal Hospital, Suzhou, Jiangsu, 215001, China)
出处
《中国血液流变学杂志》
CAS
2017年第4期437-440,共4页
Chinese Journal of Hemorheology
