Incorporation of the central vein sign into the McDonald criteria

•CVS can be incorporated in the radiological 2017 McDonald diagnostic criteria.•Requirement of one lesion with CVS can increase specificity and accuracy.•Subcortical lesions with CVS can potentially be used to increase sensitivity. Diagnosis of multiple sclerosis (MS) frequently relies on MRI dissemination in time (DIT) and space (DIS), as codified in 2017 McDonald criteria (McD 2017). The central vein sign (CVS) is a proposed MS diagnostic biomarker, but its optimal incorporation into McD 2017 has not been extensively studied. Evaluate the diagnostic performance of several methods incorporating CVS into McD 2017 radiological DIS criteria. Data were obtained from the CAVS-MS Pilot, a cross-sectional, international multi-center study conducted by the North American Imaging in MS Cooperative (NAIMS) that recruited adults referred for suspicion/diagnosis of demyelinating disease. Diagnostic performance of methods incorporating CVS into McD 2017 radiological DIS were evaluated by comparing sensitivity, specificity, and accuracy. 78 participants (37 MS, 41 others) were included. For MS diagnosis, sensitivity, specificity, and accuracy of DIS based on brain imaging (DIS-B) alone was 92 %, 69 %, and 78 %. Requiring at least one lesion with CVS in any brain location in addition to DIS-B increased specificity (sensitivity 92 %, specificity 81 %, accuracy 86 %). Presence of 2 deep white matter lesions with CVS as an additional topography for DIS-B had higher sensitivity (sensitivity 97 %, specificity 59 %, accuracy 77 %). Incorporation of CVS in McD 2017 DIS criteria can be used to improve diagnostic accuracy. Validation in additional prospective studies is needed.