【摘要】 目的:验证及评价深圳市安群生物工程有限公司研发生产的AD7c-NTP（酶联免疫吸附法）定量检测试剂盒的性能。方法:依据临床实验室标准协会（CLSI）批准的EP15-A2文件方法验证精密度及准确度,EP6-A文件方法验证线性范围,C28-A3文件方法验证生物学参考区间。结果:精密度方面:高、低浓度尿液样本批内检测结果CV分别为9.50%和4.99%,批间CV分别为13.54%和10.89%,均小于15%;准确度中:AD7c-NTP阳性质控品5次检测均值为6.512 ng/mL,标准差为0.26,CV为3.94%;分析灵敏度方面:试剂盒低值校准品A重复检测20次,浓度均值C_{校准品A+2SD校准品A}为0.086 ng/mL,光密度均值OD_{校准品A+2SD校准品A}为0.013,代入标曲中对应的浓度值为0.087 ng/mL;线性范围方面:高、低浓度混合尿液样本预期值与实测值的相关系数r为0.996;生物学参考区间方面:20份健康人尿样AD7c-NTP检测值范围为0.07～0.92 ng/mL。结论:深圳市安群生物工程有限公司研发的AD7c-NTP定量检测试剂盒的精密度、准确度、分析灵敏度、线性范围和生物学参考范围均达到了临床应用的实验要求,各性能指标的验证方法均可为相关实验室提供参考。更多还原

【Abstract】 Objective:To verify and evaluate the performance of AD7 c-NTP（ELISA） quantitative detection kit developed and produced by Shenzhen Anqun Biological Engineering Co.,Ltd..Methods:The precision and accuracy were verified according to the EP15-A2 document method approved by the Clinical and Laboratory Standards Institute（CLSI）,the linear range was verified by EP6-A document method, and the biological reference interval was verified by C28-A3 document method.Results:The intra-batch precision test results showed that the high and low concentration urine samples were 9.50% and 4.99%, respectively, and the inter-batch CV were 13.54% and 10.89%,respectively, both of which were less than 15%.In terms of accuracy, the average value of AD7 c-NTP positive quality control products was 6.512 ng/mL,and the standard deviation was 0.26,CV was 3.94%.In the sensitivity verification of the analysis, the low value calibrator A in the kit was repeatedly tested for 20 times, the detection concentration mean C_{calibrator A+2 SD calibrator A} was 0.086 ng/mL,the optical density mean OD _{calibrator A+2 SD calibrator A} was 0.013,and the corresponding concentration value in the standard koji was 0.087 ng/mL.In terms of linear range verification, the correlation coefficient between the predicted value and the measured value of high and low concentration mixed urine samples was 0.996.In the biological reference interval verification, the range of AD7 c-NTP detection values of 20 healthy urine samples was 0.07～0.92 ng/mL.Conclusion:The precision, accuracy, analytical sensitivity, linear range and biological reference range of the AD7 c-NTP quantitative detection kit developed by Shenzhen Anqun Biological Engineering Co.,Ltd.can meet the experimental requirements of clinical application, and the verification methods of each performance index can provide reference for related laboratories.更多还原