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Clinical validation of a multi-protein, serum-based assay for disease activity assessments in multiple sclerosis

2023; Elsevier BV; Volume: 253; Linguagem: Inglês

10.1016/j.clim.2023.109688

1521-7035

Tanuja Chitnis, John Foley, Carolina Ionete, Nabil K. El Ayoubi, Shrishti Saxena, Patricia Gaitan-Walsh, Hrishikesh Lokhande, Anu Paul, Fermisk Saleh, Howard L. Weiner, Ferhan Qureshi, Michael J. Becich, Fátima Rubio da Costa, Victor M. Gehman, Fujun Zhang, Anisha Keshavan, Kian Jalaleddini, Ati Ghoreyshi, Samia J. Khoury,

Peripheral Neuropathies and Disorders

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.