一种国产胃泌素释放肽前体化学发光免疫试剂的性能验证

The Performance Verification of a Domestic Gastrin-releasing Peptide for Chemiluminescence Immunoreagent

目的 胃泌素释放肽前体(progastrin- releasing peptide,proGRP)是鉴别小细胞肺癌(small cell lung cancer,SCLC)与非小细胞肺癌(non- small cell lung cancer,NSCLC)及其他良性肺部疾病的重要标志物。长光华医研发生产了proGRP化学发光免疫分析试剂(chemiluminesent immunoassay,CLIA),厂家声明,该试剂精密性<10%,检出限为5pg/mL,回收率在±10%之间,参考区间为<65pg/mL,线性范围为15~3000pg/mL,血清与血浆相关性良好,血清稳定性可达96 h,与Roche电化学发光法proGRP试剂相关性良好。在此对该试剂进行了性能验证。方法 采取美国临床实验室标准化协会(CLSI)文件推荐的方法及美国病理家协会CAP要求,对该国产proGRP检测试剂盒及配套仪器AE- 180检测系统进行精密度、分析灵敏度、回收率、线性范围、参考区间、血清血浆一致性及血清稳定性进行性能验证,并跟罗氏e601系统平行检测199例包括健康体检样本、小细胞肺癌、非小细胞肺癌及良性肺部疾病样本,比较2种检测系统结果的一致性。结果 该国产化学发光proGRP精密性良好,批内变异系数在2.8%~3.2%,总变异系数为4.3%~5.2%;检出限为5pg/mL;回收率在90.6%~105.2%;参考区间为<65 pg/mL;线性范围为15~3000 pg/mL;血清与EDTA血浆相关性良好;血清稳定性可达96 h;与Roche电化学发光法检测结果相关系数为0.99,斜率和截距分别为0.9889和1.28 pg/mL,相关性良好。结论该国产CLIA 法检测proGRP 性能参数和厂商声明一致,其性能可以满足临床要求。

Objective ProGRP is a promising effective tumor marker in discriminating SCLC from NSCLC and other benign lung diseases.ProGRP Chemiluminescent immunoassay(CLIA)was developed and manufactured by Hybiome.The manufacturer declared the performance parameters as following:the precision of the reagent was less than 10%,the limit of detection was 5 pg/mL,the recovery was between <±10%,the reference range was <65 pg/mL,the linear range was 15- 3000 pg/mL,the serum was well correlated with plasma,and the serum stability could reach 96 hours,and the correlation with Roche electrochemiluminescence proGRP reagent was good.The performance of the reagent was verified in this study. Methods According to the CLSI and CAP,the precision,limit of quantitation,recovery rate,linear range,reference interval,serum plasma consistency,serum stability and complement interference of the domestic proGRP assay and its supporting instrument,AE- 180 detection system,were verified.199 case samples from healthy control,small cell lung cancer,non- small cell lung cancer and benign lung disease patients,were detected in parallel with Roche E601 system to compare the consistency of the results between the two detection systems. Results The new ProGRP assay demonstrated satisfied performances:the precision was good,the coefficient of variation in batches was 2.8%- 3.2%,the coefficient of variation between batches was 4.3%- 5.2%;the limit of detection was 5 pg/mL;the recovery rate was 90.6%- 105.2%;the reference interval was < 65 pg/mL;the linear range was 15- 3000 pg/mL;The correlation coefficient between serum and EDTA plasma was 0.9921;the stability of serum could reach 96 hours.Furthermore,the correlation coefficient between the two methods was 0.99,with the slope and intercept of 0.9889 and 1.28 pg/mL,respectively. Conclusion The performance parameters of the evaluated proGRP detection system are consistent with the manufacturer′s statement,and its performance can meet the clinical requirements.