Abstract
BackgroundDiabetic retinopathy (DR) is the most frequent cause of blindness among younger adults in the western world. No blood biomarkers exist to detect DR. Hypothetically, Rhodopsin concentrations in blood has been suggested as an early marker for retinal damage. The aim of this study was therefore to develop and validate a Rhodopsin assay by employing digital ELISA technology, and to investigate whether Rhodopsin concentrations in diabetes patients with DR are elevated compared with diabetes patients without DR. MethodsA digital ELISA assay using a Simoa HD-1 Analyzer (Quanterix©, Lexington, MA 02421, USA) was developed and validated and applied on a cohort of diabetes patients characterised with (n=466) and without (n=144) DR. ResultsThe Rhodopsin assay demonstrated a LOD of 0.26ng/l, a LLOQ of 3ng/l and a linear measuring range from 3 to 2500ng/l. Total CV% was 32%, 23%, 19% and 17% respectively at the following Rhodopsin concentrations: 1, 3, 5 and 13ng/l. Recovery was 17%, 34%, 51% and 55% respectively at Rhodopsin concentrations of 2, 10, 50 and 250ng/l. There was no statistically significant difference in the plasma concentration of Rhodopsin between the diabetes patients with or without DR, but significantly increased number of DR patients having concentrations above the LOD. ConclusionWe developed and validated a digital ELISA method for quantification of Rhodopsin in plasma but found no statistically significant difference in the plasma concentration of Rhodopsin between diabetes patients with DR compared to diabetes patients without DR, though significantly more DR patients had values above the LOD.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.