, a new study indicates.
The presence of oligoclonal bands is “very specific for MS and is obtained by lumbar puncture, which is invasive and can be unpleasant, so it is not an ideal test,” said study investigator Daniel Ontaneda, MD, PhD, with the Mellen Center for MS Treatment and Research at the Cleveland Clinic.
In a pilot study, the central vein sign was “highly correlated with the presence of oligoclonal bands and in many cases could serve to prove that a person has MS without the need for a spinal tap,” Dr. Ontaneda said.
The study was presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Reducing the need for lumbar puncture
Oligoclonal bands in cerebrospinal fluid are commonly used as a diagnostic biomarker for MS and can serve to meet the requirement for dissemination in time in the 2017 McDonald criteria. Central vein sign is an emerging neuroimaging biomarker for MS that may improve diagnostic accuracy and reduce the need for lumbar puncture.
For the study, the investigators compared the sensitivity, specificity, and positive predictive value of central vein sign on MRI with that of oligoclonal bands in cerebrospinal fluid for MS diagnosis.
Among the 53 participants, 24 (45%) met 2017 McDonald criteria for dissemination in space and time at baseline, and 27 (51%) met the criteria at 12-month follow-up.
At initial presentation, sensitivity for MS diagnosis was 75% for oligoclonal bands, 83% for central vein sign “Select-3” (3 central vein sign–positive lesions per scan), and 71% for central vein sign “Select-6” (6 central vein sign–positive lesions per scan).
The point estimate of sensitivity of central vein sign was higher than of oligoclonal bands, but there was no significant difference in sensitivities across methods.
Specificity at initial presentation was 76% for oligoclonal bands, 48% for Select-3, and 86% for Select-6.
The presence of oligoclonal bands was more specific than Select-3 for diagnosis of MS at initial presentation (P = .03), as was Select-6 (P = .001). There was no significant difference when comparing cerebrospinal fluid oligoclonal bands with central vein sign Select-6.
At 12-month follow-up, the positive predictive value was 84% for oligoclonal bands and 95% for Select-6; combining oligoclonal bands and Select-6 gave a positive predictive value of 100%.
Dr. Ontaneda said that on the basis of these promising pilot data, the researchers have secured funding from the National Institutes of Health for a prospective study to further investigate the central vein sign as a potential biomarker for MS.
He also said there is “active discussion as to whether central vein sign should be added to the diagnostic criteria for MS.
“We think that it’s probably about time that we have diagnostic biomarkers that are sensitive and specific and can help us do away with complicated criteria to make the diagnosis, in favor of an imaging biomarker,” Dr. Ontaneda said.