Label-free porous silicon immunosensor for broad detection of opiates in a blind clinical study and results comparison to commercial analytical chemistry techniques.
Label-free porous silicon immunosensor for broad detection of opiates in a blind clinical study and results comparison to commercial analytical chemistry techniques.
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DOI：
10.1021/ac101804s
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发表时间：
2010-12-01
影响因子：
7.4
通讯作者：
DeLouise, Lisa A.
中科院分区：
文献类型：
--
作者：
Bonanno, Lisa M.;Kwong, Tai C.;DeLouise, Lisa A.
在这项工作中，我们首次评估了一种无标记多孔硅(PSI)免疫传感器试验在一项盲目临床研究中的性能，该试验旨在筛选各种阿片类药物的真实患者尿样。PSI阿片免疫传感器与液质联用(LC-MS/MS)检测结果的符合率为96%。此外，成功检测到一种常见的滥用阿片类药物羟考酮，使PSI阿片传感器与LC-MS/MS之间的定性符合率达到100%。相比之下，商用广谱阿片免疫分析技术(CEDIA®)与LC-MS/MS的定性符合率达到65%。对添加了测试分析物的空白尿样进行了精密度、准确性和回收率等重要性能属性的评估。作为模型阿片靶标的吗啡检测的变异系数在运行内和日间均为9%，超过300ngmlPSI 1的截止限值。这项研究验证了无标记−阿片免疫传感器在真实患者样本中的分析筛选能力，并首次半定量展示了该技术的成功临床应用。这些结果推动了PSI技术的未来发展，以降低诊断测试的复杂性和成本，特别是在医疗保健环境中。
In this work we evaluate for the first time the performance of a label-free porous silicon (PSi) immunosensor assay in a blind clinical study designed to screen authentic patient urine specimens for a broad range of opiates. The PSi opiate immunosensor achieved 96% concordance with liquid chromatography-mass spectrometry/tandem mass spectrometry (LC-MS/MS) results on samples that underwent standard opiate testing (n=50). In addition, successful detection of a commonly abused opiate, oxycodone, resulted in 100% qualitative agreement between the PSi opiate sensor and LC-MS/MS. In contrast, a commercial broad opiate immunoassay technique (CEDIA®) achieved 65% qualitative concordance with LC-MS/MS. Evaluation of important performance attributes including precision, accuracy, and recovery was completed on blank urine specimens spiked with test analytes. Variability of morphine detection as a model opiate target was < 9% both within-run and between-day at and above the cutoff limit of 300 ng ml−1. This study validates the analytical screening capability of label-free PSi opiate immunosensors in authentic patient samples and is the first semi-quantitative demonstration of the technology’s successful clinical use. These results motivate future development of PSi technology to reduce complexity and cost of diagnostic testing particularly in a point-of-care setting.
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影响因子：
9.3
作者：
Ellington AA;Kullo IJ;Bailey KR;Klee GG
通讯作者：
Klee GG
影响因子：
7.4
作者：
DeLouise, LA;Miller, BL
通讯作者：
Miller, BL
影响因子：
56.9
作者：
Li, YY;Cunin, F;Sailor, MJ
通讯作者：
Sailor, MJ
影响因子：
7.4
作者：
Bonanno, Lisa M.;DeLouise, Lisa A.
通讯作者：
DeLouise, Lisa A.
影响因子：
56.9
作者：
Lin, VSY;Motesharei, K;Ghadiri, MR
通讯作者：
Ghadiri, MR