The innovation of this work lies in the trace detection of inflammatory biomarkers (IL-6, hs-CRP) in human exhaled breath condensate on the developed EBC-SURE platform as a point-of-care aid for respiratory disorder diagnosis. The unique design of the EBC-SURE leverages non-faradaic electrochemical impedance spectroscopy to capture target-specific biomolecular interactions for highly sensitive biomarker detection. For sensor calibration, EBC-SURE's performance is assessed to measure the response of the sensor to a known concentration by spike and recovery analysis with a recovery error of <20% and an extended dynamic range over 3-log orders. The lowest detection limits for IL-6 and hs-CRP detection in EBC were found to be 3.2 pg/mL and 4 pg/mL respectively. The intra-assay and inter-assay efficacy of EBC-SURE for its usage as a diagnostic device was established through repeatability and reproducibility (over 48 h s) performance testing. The percentage variations (<20%) met the Clinical and Laboratory Standards Institute standards (CLSI) indicating a highly stable performance for robust biomarker detection. EBC-SURE generated highly selective IL-6 and hs-CRP responses in the presence of other non-specific cytokines. Statistical validation methods- Correlation and Bland Altman analysis established the one-to-one agreement between EBC-SURE and the reference method. Correlation analysis generated a Pearson's R value of 0.99 for IL-6 and hs-CRP. Bland-Altman analysis indicated a good agreement between both the methods with all data points confined within the ±2SD limits. We have demonstrated EBC-SURE's ability in detecting inflammatory biomarkers in human breath condensate towards developing a non-invasive technology that can quantify biomarker levels associated with healthy and acute inflammatory conditions.
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| http://dx.doi.org/10.1016/j.bios.2022.114117 | DOI Listing |
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