ABSTRACT
BACKGROUND: Lung cancer is the second leading cause of death in the United States. Lung cancer is often diagnosed in its late stage leading to a poor prognosis. Lung nodules are often described as indeterminate from CT scans resulting in lung biopsies that are invasive and may lead to complications. The need for noninvasive methods to assess malignancy risk in lung nodules is great. METHODS: The lung nodule risk reclassifier assay consists of 7 protein biomarkers: Carcinoembryonic Antigen (CEA), C-X-C Motif Chemokine Ligand 10 (CXCL10), Epidermal Growth Factor Receptor (EGFR), Neutrophil Activating Protein-2 (NAP2), Pro-surfactant Protein B (ProSB), Receptor for Advanced Glycation Endproducts (RAGE), and Tissue Inhibitor of Metalloproteinase Inhibitor 1 (TIMP1) and 6 clinical factors (subject age, smoking pack years, and sex, and lung nodule size, location, and spiculated appearance). The protein biomarker assays comprise a multiplex immunoassay panel printed on giant magnetoresistance (GMR) sensor chips as components of a printed circuit board (PCB) run on the MagArray MR-813 instrument system. The analytical validation consisted of imprecision, accuracy, linearity, limits of blank, and limits of detection studies for each biomarker. Several reagents, as well as PCBs, were used in these studies. The entire validation study also assessed multiple users. RESULTS: This laboratory-developed test (LDT), using the MagArray platform, meets the manufacturer's specifications for imprecision, analytical sensitivity, linearity, and recovery. Common biological interferents are known to interfere with the detection of each biomarker. CONCLUSIONS: The lung nodule risk reclassifier assay performed as required to be offered as an LDT in the MagArray CLIA-certified laboratory.
Subject(s)
Biomarkers, Tumor , Lung Neoplasms , Humans , United States , Receptor for Advanced Glycation End Products , Lung Neoplasms/diagnosis , Lung , Tomography, X-Ray Computed/methodsABSTRACT
In this report, we demonstrated a handheld wireless voltage-clamp amplifier for current measurement of nanopore sensors. This amplifier interfaces a sensing probe and connects wirelessly with a computer or smartphone for the required stimulus input, data processing and storage. To test the proposed Signal Transduction by Ion Nanogating (STING) wireless amplifier, in the current study the system was tested with a nano-pH sensor to measure pH of standard buffer solutions and the performance was compared against the commercial voltage-clamp amplifier. To our best knowledge, STING amplifier is the first miniaturized wireless voltage-clamp platform operated with a customized smart-phone application (app).
