雅培i1000SR全自动化学发光分析仪检测DHEA-S和SHBG的性能验证

Performance verification of ARCHITECT i1000SR automatic chemiluminescence analyzer for detecting DHEA-S and SHBG

目的验证评价雅培i1000SR全自动化学发光分析仪使用化学发光微粒子免疫分析法检测硫酸脱氢表雄酮(dehydroepiandrosterone sulfate,DHEA-S)、性激素结合球蛋白(sex hormone-binding globulin,SHBG)的性能。方法根据ISO15189《医学实验室质量和能力认可准则》要求,同时参照美国临床实验室标准协会CLSI EP系列文件以及相关标准,本研究使用雅培i1000SR于2020年3月对各质控品和临床样本进行DHEA-S、SHBG的非随机对照实验性研究,对DHEA-S、SHBG进行精密度、正确度以及线性范围验证,最后将验证结果与厂家声称性能指标进行相比。结果DHEA-S浓度水平1和水平2验证的批内CV、总CV分别为1.20%、3.68%和1.48%、1.70%,SHBG浓度水平1和水平2验证的批内CV、总CV分别为4.00%、0.80%和4.94%、2.03%,二者均小于厂家声明的6.25%的批内CV和8.33%的总CV,精密度验证通过。DHEA-S的5份质控品其验证偏差结果分别为-7.0%、-6.8%、-4.8%、4.7%和-2.5%,SHBG的5份质控品其验证偏差结果分别为-4.5%、-3.7%、-1.4%、-2.5%和-2.1%,结果均小于±12.5%,即总允许误差(TEa)的1/2,正确度符合实验室要求;DHEA-S、SHBG验证的线性范围是5.10~1301.07μg/dL和1.90~221.13 nmol/L,均在厂家线性范围内,二者具有良好的线性关系(DHEA-S的R2=0.9993,SHBG的R2=0.9966,相关系数R2>0.95);测定结果准确可靠,精密度较高,准确度较高,线性范围宽,以上性能指标均符合厂家声称的性能要求。结论雅培i1000SR全自动化学发光分析仪检测DHEA-S、SHBG的性能验证的结果均符合临床的要求,可用于大批量临床标本的检测,DHEA-S、SHBG对性激素相关疾病的诊断具有重要价值。

Objective To verify and evaluate the methodological performance of chemiluminescence microparticle immunoassay in the ARCHITECT i1000SR automatic chemiluminescence analyzer for detecting dehydroepiandrosterone sulfate(DHEA-S)and sex hormone-binding globulin(SHBG).Methods According to the requirements of the Accreditation Criteria for the Quality and Competence of Medical Laboratories(ISO15189),as well as referring to EP series documents of CLSI and related standards,in March 2020,ARCHITECT i1000SR was used to to measure the trial results of DHEA-S and SHBG in each quality control product and clinical sample to verify their precisions,accuracies,and line ranges,and were compared with the manufacturer's stated performance indicators.Results The within-run CV and total CV of DHEA-S were 1.20%and 3.68%on level 1,and were 1.48%and 1.70%on level 2;the within-run CV and total CV of SHBG were 4.00%and 0.80%on level 1,and were 4.94%and 2.03%on level 2;which were all smaller than those of the inter-laboratory quality assessment standards——6.25%and 8.33%;it suggested that the manufacturer's claims were verifiable.The deviations of DHEA-S'5 controls were-7.0%,-6.8%,-4.8%,4.7%,and-2.5%,and those of SHBG's were-4.5%,-3.7%,-1.4%,-2.5%,and-2.1%,which were all smaller than±12.5%,1/2 TEa,and met the laboratory declaration requirements.The validation line arrange of DHEA-S was 5.10-1301.07μg/dL,and that of SHBG 1.90-221.13 nmol,and both were within the manufacturer's range,showing a good linearity relation(DHEA-S:R2=0.9993;SHBG:R2=0.9966;correlation coefficient R2>0.95).The detection results were accurate and reliable,with high precision,high accuracy,and wide line range.All the above performance indicators met the manufacturer's requirements.Conclusion The performance verification results of the ARCHITECT i1000SR automatic chemiluminescence analyzer for the detection of DHEA-S and SHBG meet the clinical requirements,and can be used for the detection of large quantities of clinical specimens.DHEA-S and SHBG have important value in the diagnosis of sex hormone related diseases.