Abstract：
OBJECTIVE: This study performed an analytical validation study of the Mindray high-sensitivity cardiac troponin I (hs-cTnI) assay addressing limit of blank (LoB), limit of detection (LoD), precision, linearity, analytical specificity and sex-specific 99th percentile upper reference limits.
METHODS: LoB, LoD, precision, linearity and analytical specificity were studied according to Clinical and Laboratory Standards Institute. We used one reagent lot and one CL1200i analyzer. Skeletal troponin I and T, cardiac troponin T, troponin C, actin, tropomyosin, myosin light chain, myoglobin and creatine kinase (CK-MB) were studied for cross-reactivity. Interference with biotin was examined. Lithium heparin samples (one freeze thaw cycle) from healthy males and females were measured to determine the 99th percentiles by using the non-parametric method. Analyses were performed before and after excluding subjects with clinical conditions and/or increased surrogate biomarkers.
RESULTS: The Mindray hs-cTnI assay met criteria to be considered as a hs-cTn assay. LoB and LoD was <0.1 ng/L and 0.1 ng/L, respectively. Repeatability had a coefficient of variation 1.2-3.8 %, and within-laboratory imprecision 1.7-5.0 %. The measuring interval ranged from 1.1 to 28,180 ng/L. The analytical specificity was clinically acceptable for the interferents studied. After exclusions, the 99th percentile URLs obtained were 10 ng/L overall, 5 ng/L for females and 12 ng/L for males.
CONCLUSIONS: Analytical observations of the Mindray hs-cTnI assay demonstrated excellent LoB, LoD, precision, linearity and analytical specificity, that were in alignment with the manufacturer\'s claims and regulatory guidelines for hs-cTnI. The assay is suitable for clinical investigation for patient-oriented studies.
METHODS: LoB, LoD, precision, linearity and analytical specificity were studied according to Clinical and Laboratory Standards Institute. We used one reagent lot and one CL1200i analyzer. Skeletal troponin I and T, cardiac troponin T, troponin C, actin, tropomyosin, myosin light chain, myoglobin and creatine kinase (CK-MB) were studied for cross-reactivity. Interference with biotin was examined. Lithium heparin samples (one freeze thaw cycle) from healthy males and females were measured to determine the 99th percentiles by using the non-parametric method. Analyses were performed before and after excluding subjects with clinical conditions and/or increased surrogate biomarkers.
RESULTS: The Mindray hs-cTnI assay met criteria to be considered as a hs-cTn assay. LoB and LoD was <0.1 ng/L and 0.1 ng/L, respectively. Repeatability had a coefficient of variation 1.2-3.8 %, and within-laboratory imprecision 1.7-5.0 %. The measuring interval ranged from 1.1 to 28,180 ng/L. The analytical specificity was clinically acceptable for the interferents studied. After exclusions, the 99th percentile URLs obtained were 10 ng/L overall, 5 ng/L for females and 12 ng/L for males.
CONCLUSIONS: Analytical observations of the Mindray hs-cTnI assay demonstrated excellent LoB, LoD, precision, linearity and analytical specificity, that were in alignment with the manufacturer\'s claims and regulatory guidelines for hs-cTnI. The assay is suitable for clinical investigation for patient-oriented studies.
摘要：
目的：本研究对Mindray高敏心肌肌钙蛋白I（hs-cTnI）测定空白极限（LoB）进行了分析验证研究，检测限(LoD)，精度,线性度分析特异性和性别特异性第99百分位数参考上限。
方法：LoB，LoD,精度,根据临床和实验室标准研究所研究线性和分析特异性。我们使用了一个试剂批次和一个CL1200i分析仪。骨骼肌肌钙蛋白I和T,心肌肌钙蛋白T,肌钙蛋白C,肌动蛋白，原肌球蛋白,肌球蛋白轻链,研究了肌红蛋白和肌酸激酶（CK-MB）的交叉反应性。检测生物素的干扰。通过使用非参数方法测量来自健康男性和女性的肝素锂样品(一个冻融循环)以确定第99百分位数。在排除具有临床状况和/或增加的替代生物标志物的受试者之前和之后进行分析。
结果：迈瑞hs-cTnI测定符合被认为是hs-cTn测定的标准。LoB和LoD分别<0.1ng/L和0.1ng/L，分别。重复性的变异系数为1.2-3.8%，和实验室内的不精确性1.7-5.0%。测量间隔范围为1.1至28,180ng/L。对于所研究的干扰物,分析特异性在临床上是可接受的。排除后，获得的第99百分位数URL总体为10ng/L，女性为5ng/L，男性为12ng/L。
结论：对Mindrayhs-cTnI测定的分析观察结果证明了出色的LoB，LoD,精度,线性和分析特异性，这符合制造商对hs-cTnI的索赔和监管准则。该测定法适用于面向患者的研究的临床研究。
方法：LoB，LoD,精度,根据临床和实验室标准研究所研究线性和分析特异性。我们使用了一个试剂批次和一个CL1200i分析仪。骨骼肌肌钙蛋白I和T,心肌肌钙蛋白T,肌钙蛋白C,肌动蛋白，原肌球蛋白,肌球蛋白轻链,研究了肌红蛋白和肌酸激酶（CK-MB）的交叉反应性。检测生物素的干扰。通过使用非参数方法测量来自健康男性和女性的肝素锂样品(一个冻融循环)以确定第99百分位数。在排除具有临床状况和/或增加的替代生物标志物的受试者之前和之后进行分析。
结果：迈瑞hs-cTnI测定符合被认为是hs-cTn测定的标准。LoB和LoD分别<0.1ng/L和0.1ng/L，分别。重复性的变异系数为1.2-3.8%，和实验室内的不精确性1.7-5.0%。测量间隔范围为1.1至28,180ng/L。对于所研究的干扰物,分析特异性在临床上是可接受的。排除后，获得的第99百分位数URL总体为10ng/L，女性为5ng/L，男性为12ng/L。
结论：对Mindrayhs-cTnI测定的分析观察结果证明了出色的LoB，LoD,精度,线性和分析特异性，这符合制造商对hs-cTnI的索赔和监管准则。该测定法适用于面向患者的研究的临床研究。
