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 | 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.