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Observational Study
. 2023 Jan:69:104443.
doi: 10.1016/j.msard.2022.104443. Epub 2022 Dec 5.

Limited diagnostic utility of serologic testing for neurologic manifestations of systemic disease in the evaluation of suspected multiple sclerosis: A single-center observational study

Anna A Shah  1 , Jessica Piche  2 , Benjamin Stewart  3 , Colin Lyness  3 , Brian Callaghan  2 , Andrew J Solomon  4
Affiliations
Observational Study

Limited diagnostic utility of serologic testing for neurologic manifestations of systemic disease in the evaluation of suspected multiple sclerosis: A single-center observational study

Anna A Shah et al. Mult Scler Relat Disord. 2023 Jan.

Abstract

Background: The clinical evaluation of a new diagnosis of MS typically includes serologic testing to evaluate for its many mimics, yet there is little data to guide approaches to such testing.

Objective: To evaluate for the frequency and clinical significance of serologic testing for MS diagnostic evaluations.

Methods: In a single MS subspeciality center retrospective study, new patient evaluations for MS over the course of a year were identified, and the results of serologic testing and diagnostic evaluation extracted. Retrospective longitudinal diagnostic assessment was performed to confirm the accuracy of initial serological testing assessments.

Results: 150 patients had 823 serologic tests. 40 (5%) tests were positive, and resulted in 117 additional serologic tests, 10 radiographs, and 2 biopsies. 77 (51%) patients were diagnosed with a non-demyelinating disorder. Serologic testing results did not change any diagnosis, yet in some patients, it resulted in unnecessary additional testing and diagnostic delay.

Conclusions: Serologic testing in the clinical assessment for routine MS resulted in unnecessary diagnostic delay, additional testing, and considerable healthcare cost.

Keywords: Differential diagnosis; False positives; Mimics; Misdiagnosis; Multiple sclerosis; Multiple sclerosis mimics; Serologic testing; Serum testing.

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Conflict of interest statement

Declaration of Competing Interest Anna A Shah, MD - I have participated in advisory boards through Genentech and TG therapeutics. I have received funding for non-promotional educational programming through NCQA, Novartis and Rocky Mountain MS Center. Brian Callaghan, MD – I receive research contracts and I am on the editorial board for the American Academy of Neurology. I consult for Dynamed. I perform medicolegal consultations including for the Vaccine Injury Compensation Program. Andrew J Solomon, MD - Consulting or Advisory Boards: EMD Serono, Genentech, Biogen, Alexion, Celgene, Greenwich Biosciences, TG Therapeutics, Octave Bioscience. Non-Promotional Speaking: EMD Serono. Research Funding: Bristol Myers Squibb and Biogen. Contracted Research: Sanofi, Biogen, Novartis, Actelion, Genentech/Roche. Medicolegal consultations including expert witness testimony. Colin Lyness, MD, Jessica Piche, MD, and Benjamin Stewart, MD, have no reportable conflicts of interest.

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