Label-free porous silicon immunosensor for broad detection of opiates in a blind clinical study and results comparison to commercial analytical chemistry techniques.
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 semiquantitative demonstration of the technology's successful clinical use. These results motivate future development of label-free PSi technology to reduce complexity and cost of diagnostic testing particularly in a point-of-care setting.
Department of Biomedical Engineering, University of Rochester, Rochester, New York, USA.
Lisa M
LM
Bonanno
Tai C
TC
Kwong
Lisa A
LA
DeLouise
D000701:Analgesics, Opioid / Q000652:urine*; D015374:Biosensing Techniques / Q000379:methods*; D002851:Chromatography, High Pressure Liquid; D008401:Gas Chromatography-Mass Spectrometry; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D013058:Mass Spectrometry; D009020:Morphine / Q000652:urine; D010098:Oxycodone / Q000652:urine*; D019095:Point-of-Care Systems; D016062:Porosity; D012825:Silicon / Q000737:chemistry*
D000701:Analgesics, Opioid; D009020:Morphine; D010098:Oxycodone; D012825:Silicon