高敏化学发光免疫分析系统在激素检测中的性能评估  

An Evaluation of the Performance of High-sensitivity ChemiluminescenceImmunoassay System in Hormone Detection

作　　者：徐东[1] 陈陆[1] 曹正 谢杰施 翟燕红[1] XU Dong;CHEN Lu;CAO Zheng;XIE Jieshi;ZHAI Yanhong(Department of Laboratory Medicine,Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing Maternal and Child Health Care Hospital,Beijing 100026,China)

机构地区：[1]首都医科大学附属北京妇产医院/北京妇幼保健院检验科,北京100026

出　　处：《标记免疫分析与临床》2024年第11期2078-2084,共7页Labeled Immunoassays and Clinical Medicine

基　　金：基于实验室自建方法的血清IGF-1飞行时间质谱定量检测性能评估(编号:PX2024053)。

摘　　要：目的对希森美康HSCL5000高敏化学发光免疫分析系统在激素检测中的临床性能进行评估,并与ci16200和Centaur XP检测系统进行结果比较。方法在相同的实验条件下利用不同检测系统对各激素项目的高值和低值标本重复检测4次,连续检测5d,计算并比较各检测系统的检测不精密度;在相同实验条件下,利用不同检测系统对尽可能覆盖各项激素检测范围的样本进行检测,分析不同检测系统检测结果的一致性;利用HSCL5000检测系统对各激素可溯源的高值标准品及其倍比稀释后的样品进行重复检测,计算检测均值和理论值之间的相关性;利用HSCL5000检测系统对各激素可溯源的高值和低值标准品进行重复检测,计算检测结果均值与靶值之间的偏倚。结果HSCL5000检测系统对各激素检测的不精密度均在能力验证允许范围之内,且卵泡刺激素(FSH)、睾酮(T)、泌乳素(PRL)的不精密度优于Centaur XP检测系统,人绒毛膜促性腺激素(hCG)和孕酮(P)低值标本的不精密度优于ci16200;HSCL5000与ci16200检测系统在hCG和P的检测中,HSCL5000与Centaur XP检测系统在雌二醇(E 2)、FSH、LH、T和PRL的检测中,结果均具有较好的一致性(r>0.975);HSCL5000检测系统对各激素标准品的检测结果均值与理论值之间具有较好的相关性(r>0.975);HSCL5000检测系统对标准品的检测结果均值与靶值之间的偏倚均在±0.15之内。结论希森美康HSCL5000高敏化学发光免疫分析系统对常规激素检测的临床性能验证均可通过,且与ci16200和Centaur XP检测系统的检测结果一致性较好,在临床中具有较好的应用价值。Objective To evaluate the clinical performance of the HSCL5000 high-sensitive chemiluminescence immunoassay system in hormone detection,and to further compare the results with ci16200 and Centaur XP detection systems.Methods Under the same experimental conditions,the high-and low-value specimens of each hormone were detected repeatedly by different detection systems 4 times for 5 consecutive days,and the detection imprecision of each detection system was calculated and compared;Different detection systems were used to detect the hormones samples covering the detection range as far as possible,and the results consistency of different detection systems was evaluated;The high-value traceable standard products and the gradient diluted samples of each hormone were detected repeatedly by HSCL5000 test system,and the correlation between the test mean and the theoretical value was calculated;Repeated detection of the high and low value of each hormone traceable standard were performed by HSCL5000 detection system,and the bias between the mean value of the detection results and the target values was calculated.Results The imprecision of HSCL5000 detection system for each hormone was within the allowable range of capability verification,and the imprecision of follicle stimulating hormone(FSH),testosterone(T)and prolactin(PRL)was better than that of Centaur XP,while the imprecision of human chorionic gonadotropin(hCG)and progesterone(P)low value specimens was better than ci16200;Both hCG and P results in HSCL5000 and ci16200 detection systems and estradiol(E 2),FSH,LH,T,PRL results in HSCL5000 and Centaur XP detection systems showed a good consistency(r>0.975);HSCL5000 test system had a good correlation between the mean value and the theoretical value of each hormone standard(r>0.975);The bias between the mean value and the target value of the HSCL5000 test system for the standard product was within±0.15.Conclusion HSCL5000 hypersensitive chemiluminescence immunoassay system is able to pass the clinical performance verific

关 键 词：HSCL5000高敏化学发光免疫分析系统 激素 不精密度 结果一致性 正确度 

分 类 号：R-331[医药卫生]