Development of a novel microsampling device to standardize the analysis of intranasal inflammatory biomarkers

Nasal fluid biomarker analysis is an emerging technique for studying sinonasal pathophysiology, monitoring therapeutic efficacy, and discovering novel drug targets. Variability in biomarker results can be contributed to non-standardized collection methodology. To address this, a novel microsampler was developed, designed to enable precise site-specific sampling, consistent volume collection, and high analyte recovery. This study aims to evaluate the performance of this new microsampler device compared to commonly utilized flocked swab, and other absorbent materials. To do so, fixed volumes of a synthetic nasal fluid mimic were deposited onto the anterior region of the inferior turbinate of a 3D-printed sinus model to assess volumetric and collection site accuracy of the nasal microsampler, in comparison to a flocked swab. Additionally, protein biomarker recovery properties of the device's absorption membrane, Leukosorb^TM, versus experimental proprietary absorbent materials, were assessed using ELISA. The microsampler, contrasting the flocked swab, demonstrated statistically significant lower coefficient of variation for collected nasal fluid volume and greater sampling site precision. The spike and recovery study indicated that the proprietary materials had statistically significant higher biomarker recovery rates than Leukosorb^TM. Overall, the novel nasal microsampler offers significantly improved volumetric control and site-specific collection against flocked swab. All experimental proprietary absorbent materials displayed significantly higher protein recovery rates, comparing to widely accepted and utilized Leukosorb^TM. Consistent use of the novel nasal microsampler device has the potential to standardize protein recovery processes and minimize variability across studies, leading to enhanced reliability and comparability of future findings.