全自动荧光免疫分析仪检测17-OHP性能验证及筛查切值的建立
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摘要
目的对全自动荧光免疫分析仪(Genetic Screening Processor,GSP)检测干血斑17-羟孕酮(17-hydroxyprogesterone,17-OHP)的性能进行验证分析和评价,并初步建立该方法的先天性肾上腺皮质增生症(CAH)筛查的切值。方法前期确定验证方案,对试剂盒自带的B、D、E三个浓度的样本、L、H两个浓度水平的质控品以及试剂盒自带的6个浓度的线性标本进行GSP系统的精密度、正确度和线性范围的验证。同时以99.5百分位数确定17-OHP筛查的初始切值。结果 GSP检测B/D/E中17-OHP批内变异系数分别为6.06%、5.51%、3.63%,均小于厂家声明的8.7%;总变异系数分别为6.95%、5.80%、3.91%,低于厂家声明的最低总变异系数9.2%。检测试剂盒自带的L、H质控品浓度测量均值与靶值的相对偏差分别为5.48%、4.91%,均小于1/3允许总误差(TEa)。6个浓度线性样本的检测值和理论值的线性回归方程为:Y=1.0385X-0.6337,相关系数的平方(R~2)为1,线性相关性良好。样本总体99.5百分位数的17α-OHP水平为14.30nmol/L。结论 GSP检测干血斑17-OHP精密度、准确度、线性范围均达到了厂家声明的检测性能,可常规用于新生儿CAH筛查。本中心初步采用的GSP新生儿CAH筛查的切值为14.0nmol/L。
Objective:To verify the performance of genetic screening processor(GSP)in the measurement of 17-hydroxyprogesterone in dried blood spots and establish the cut-off value for congenital adrenal hyperplasia screening initially.Methods:The precision,accuracy and linearity were verified by testing samples of standards,controls and concentration gradient specimen. 99.5 Percentile method was used to establish cut-off value. Results:The within-run coefficient of variation(CV)for 17-OHP was 6.06%、5.51%、3.63% respectively. The total coefficient of variation was 6.95%、5.80%、 3.91% respectively.ALL of them were less than the declaration by the manufacturer. The relative deviations between the mean value of the L and H control products and the target value of the test kit was 5.48%,4.91%,respectively. The biases were<1/3 allowable total error(TEa). The equation of observed 17-OHP concentration by expected level was Y = 1.0385 X-06337,and the correlation coefficient(R2)was 1.The 17 OHP concentration of 99.5 Percentile was 14.30 nmol/L.Conclusion:The precision,accuracy and linear range of GSP have been meet the performance of manufacturers′ declaration and could be used for neonatal screening. The initial cut-off value of CAH screening by GSP was 14.0 nmol/L.
Objective:To verify the performance of genetic screening processor(GSP)in the measurement of 17-hydroxyprogesterone in dried blood spots and establish the cut-off value for congenital adrenal hyperplasia screening initially.Methods:The precision,accuracy and linearity were verified by testing samples of standards,controls and concentration gradient specimen. 99.5 Percentile method was used to establish cut-off value. Results:The within-run coefficient of variation(CV)for 17-OHP was 6.06%、5.51%、3.63% respectively. The total coefficient of variation was 6.95%、5.80%、 3.91% respectively.ALL of them were less than the declaration by the manufacturer. The relative deviations between the mean value of the L and H control products and the target value of the test kit was 5.48%,4.91%,respectively. The biases were<1/3 allowable total error(TEa). The equation of observed 17-OHP concentration by expected level was Y = 1.0385 X-06337,and the correlation coefficient(R2)was 1.The 17 OHP concentration of 99.5 Percentile was 14.30 nmol/L.Conclusion:The precision,accuracy and linear range of GSP have been meet the performance of manufacturers′ declaration and could be used for neonatal screening. The initial cut-off value of CAH screening by GSP was 14.0 nmol/L.
引文
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[6]梁晓威,程威,等.全自动免疫荧光分析仪检测苯丙氨酸的性能验证[J].南京医科大学学报(自然科学版),2018,5:699-702.
[7]王燕敏,田国力,周卓,郭静,许洪平,姚静. GSP分析仪筛查新生儿疾病的性能验证和应用.临床检验杂志,2017,2:152-154.
[8]Hayashi G,Faure C,Brondi MF,et al. Weight-adjusted neonatal 17OH-progesterone cutoff levels improve the efficiency of newborn screening for congenital adrenal hyperplasia[J]. Arq Bras Endocrinol Metabol,2011,55(8):632-637.
[9]Hayashi GY,et al. Neonatal 17-hydroxyprogesterone levels adjusted according to age at sample collection and birthweight improve the efficacy of congenital adrenal hyperplasia newborn screening[J]. Clin Endocrinol(Oxf),2017,86(4):480-487.
[2]田国力,王燕敏,周卓,郭静,许洪平,姚静.全自动新生儿疾病筛查系统的性能价[J].检验医学,2017,7:633-636.
[3]王治国.临床检验方法确认与性能验证[M].北京:人民卫生出版社,2009:246-255
[4]Simone M,Leticia F,Msc.Evaluation of the Genetic Screening Processor for the Performance of Newborn Screening Tests[J].Inborn errors of Metablism,2016,4:1-5
[5]王本敬,等.苏州地区GSP~(TM)检测17α-羟孕酮的性能验证及切值建立[J].中国优生与遗传杂志,2018,1:78-80+3.
[6]梁晓威,程威,等.全自动免疫荧光分析仪检测苯丙氨酸的性能验证[J].南京医科大学学报(自然科学版),2018,5:699-702.
[7]王燕敏,田国力,周卓,郭静,许洪平,姚静. GSP分析仪筛查新生儿疾病的性能验证和应用.临床检验杂志,2017,2:152-154.
[8]Hayashi G,Faure C,Brondi MF,et al. Weight-adjusted neonatal 17OH-progesterone cutoff levels improve the efficiency of newborn screening for congenital adrenal hyperplasia[J]. Arq Bras Endocrinol Metabol,2011,55(8):632-637.
[9]Hayashi GY,et al. Neonatal 17-hydroxyprogesterone levels adjusted according to age at sample collection and birthweight improve the efficacy of congenital adrenal hyperplasia newborn screening[J]. Clin Endocrinol(Oxf),2017,86(4):480-487.