Clinical validation of a multi-protein, serum-based assay for disease activity assessments in multiple sclerosis
Clinical Immunology, 2023
Chitnis T., Foley J., Ionete C., El Ayoubi N., Saxena S., Gaitan-Walsh P., Lokhande H., Paul A., Saleh F., Weiner H., Qureshi F., Becich M., da Costa F., Gehman V., Zhang F., Keshavan A., Jalaleddini K., Ghoreyshi A., Khoury S.
| Disease area | Application area | Sample type | Products |
|---|---|---|---|
Neurology | Technical Evaluation | Serum | O Olink Focus |
Abstract
An 18-protein multiple sclerosis (MS) disease activity (DA) test was validated based on associations between algorithm scores and clinical/radiographic assessments (N = 614 serum samples; Train [n = 426; algorithm development] and Test [n = 188; evaluation] subsets). The multi-protein model was trained based on presence/absence of gadolinium-positive (Gd+) lesions and was also strongly associated with new/enlarging T2 lesions, and active versus stable disease (composite of radiographic and clinical evidence of DA) with improved performance (p < 0.05) compared to the neurofilament light single protein model. The odds of having ≥1 Gd+ lesions with a moderate/high DA score were 4.49 times that of a low DA score, and the odds of having ≥2 Gd+ lesions with a high DA score were 20.99 times that of a low/moderate DA score. The MSDA Test was clinically validated with improved performance compared to the top-performing single-protein model and can serve as a quantitative tool to enhance the care of MS patients.