An In Vitro Diagnostic for Multiple Sclerosis Based on C-peptide Binding to Erythrocytes

基于C肽与红细胞结合的多发性硬化症体外诊断方法

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Abstract

OBJECTIVE: To investigate the utility of a blood-based lab test as an aid in identifying patients with Multiple Sclerosis (MS). METHODS: Whole blood from subjects with MS, non-MS neurologic diseases, and healthy controls was centrifuged to isolate erythrocytes. Following the addition of exogenous C-peptide, the supernatant was assayed for remaining C-peptide using an enzyme linked immunosorbent assay (ELISA). RESULTS: The cohort included subjects with MS (n=86), other non-MS neurologic diseases (OND n=75), and healthy controls (n=39). The average C-peptide bound to erythrocytes in MS samples (3.51±0.59pmol) was significantly higher than non-MS subjects (2.23±0.51pmol; p<0.001) and healthy controls (1.99±0.32pmol; p<0.001). Using a cutoff of 3.04pmol of C-peptide uptake, the test exhibited a sensitivity of 98.3% and specificity of 89.5%. A receiver-operator characteristic (ROC) curve generated from the ratio of the sensitivity to 1-selectivity resulted in an area under the curve of 0.97. CONCLUSIONS: Exogenous C-peptide binding to erythrocytes has potential value in distinguishing MS subjects from non-MS neurologic diseases and healthy controls.

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