化学发光微粒免疫分析技术检测血清人绒毛膜促性腺激素β亚基的性能评估
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摘要
目的探讨AIA-2000 ST全自动化学发光免疫分析仪检测血清人绒毛膜促性腺激素β亚基(β-HCG)的基本分析性能是否符合质量要求,确定其临床检测的可行性。方法根据国际标准化组织(ISO)15189的相关要求,对AIA-2000 ST检测血清β-HCG的重复精密度、期间精密度、正确度、线性范围(可报告范围)和参考区间进行验证和评价,并结合生产厂家给出的性能参数进行比较。结果 AIA-2000 ST全自动化学发光免疫分析仪在高、低浓度水平检测血清β-HCG的批内精密度均<1/4实验室允许总误差(TEa,1.21%、3.78%比7.50%),期间精密度均<1/3TEa(2.90%、3.78%比10.00%);正确度验证结果显示,定标液Cal 1、Cal 2的绝对偏倚(0%、2.15%)和相对偏倚(0%、1.02%)均≤1/2TEa(15%);线性范围和参考区间与厂家提供的数据基本一致,符合临床要求。结论 AIA-2000 ST全自动化学发光免疫分析仪检测血清β-HCG的主要性能验证结果与厂家声明的范围基本一致,该系统对检测血清β-HCG具有高灵敏度和高特异度,且精密度符合临床要求,可用于临床样本的检测。
Objective To investigate whether the basic analytic performance of using AIA-2000 ST fully automatic chemiluminescent immunoanalyzer to determine the level of human serum chorionic gonadotropin beta subunit(β-HCG) in accord with the quality requirements or not, and to assure the feasibility of its clinical detection. Methods According to the relevant requirements of the International Organization for Standardization(ISO) 15189, the repeated precision degree, period precision degree, accuracy, linear range(reporting range) and reference range of serum β-HCG detected by AIA-2000 ST were verified and evaluated, and combined with the performance parameters given by the manufacturer to be compared. Results By AIA-2000 ST fully automatic chemiluminescence immunoanalyzer in detecting serumβ-HCG at high and low levels, the batch precision and period precision were less than 1/4 laboratory allowable total error(TEa, 1.21%, 3.78% vs. 7.50%) and 1/3 TEa(2.90%, 3.78% vs. 10.00%) respectively. The accuracy verification results showed that the absolute bias(0%, 2.15%) and relative bias(0%, 1.02%) of calibration solution Cal 1 and Cal 2 were all ≤ 1/2 TEa(15%). The linear range and reference interval were basically consistent with the data provided by the manufacturer, and met the clinical requirements. Conclusion The results of testing the main performance of serum β-HCG by AIA-2000 ST fully automatic chemiluminescent immune analyzer are basically consistent with those parameters declared by the manufacturer. The system has high sensitivity and specificity for the detection of serum β-HCG, and its precision degree is in line with clinical requirements. Therefore, the analyzer can be used for clinical samples determination.
Objective To investigate whether the basic analytic performance of using AIA-2000 ST fully automatic chemiluminescent immunoanalyzer to determine the level of human serum chorionic gonadotropin beta subunit(β-HCG) in accord with the quality requirements or not, and to assure the feasibility of its clinical detection. Methods According to the relevant requirements of the International Organization for Standardization(ISO) 15189, the repeated precision degree, period precision degree, accuracy, linear range(reporting range) and reference range of serum β-HCG detected by AIA-2000 ST were verified and evaluated, and combined with the performance parameters given by the manufacturer to be compared. Results By AIA-2000 ST fully automatic chemiluminescence immunoanalyzer in detecting serumβ-HCG at high and low levels, the batch precision and period precision were less than 1/4 laboratory allowable total error(TEa, 1.21%, 3.78% vs. 7.50%) and 1/3 TEa(2.90%, 3.78% vs. 10.00%) respectively. The accuracy verification results showed that the absolute bias(0%, 2.15%) and relative bias(0%, 1.02%) of calibration solution Cal 1 and Cal 2 were all ≤ 1/2 TEa(15%). The linear range and reference interval were basically consistent with the data provided by the manufacturer, and met the clinical requirements. Conclusion The results of testing the main performance of serum β-HCG by AIA-2000 ST fully automatic chemiluminescent immune analyzer are basically consistent with those parameters declared by the manufacturer. The system has high sensitivity and specificity for the detection of serum β-HCG, and its precision degree is in line with clinical requirements. Therefore, the analyzer can be used for clinical samples determination.
引文
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4 孙庆燕,张娟,殷婧婧.肾素、醛固酮化学发光定量检测法的性能验证及其对原发性醛固酮增多症筛查作用探讨[J].中国实用医药,2018,13(1):74-75.
5 李家明,赖语扬,徐成坤,等.全自动血凝仪CA-7000性能及生物参考区间的验证与评价[J].实用检验医师杂志,2017,9(4):220-224.
6 朱为刚,曾劲峰,李彤,等.一种化学发光检测试剂在血液筛查中的应用评估[J].中国输血杂志,2016,29(6):581-583.
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