Variation in processes and reporting of cerebrospinal fluid oligoclonal banding and associated tests and calculated indices across Canadian clinical laboratories

V Higgins; D Beriault; A Mostafa; M P Estey; T Agbor; O Z Ismail; M L Parker

doi:10.1016/j.clinbiochem.2023.04.006

Variation in processes and reporting of cerebrospinal fluid oligoclonal banding and associated tests and calculated indices across Canadian clinical laboratories

Clin Biochem. 2023 Jun:116:105-112. doi: 10.1016/j.clinbiochem.2023.04.006. Epub 2023 Apr 24.

Authors

V Higgins¹, D Beriault², A Mostafa³, M P Estey⁴, T Agbor⁵, O Z Ismail⁴, M L Parker⁶

Affiliations

¹ DynaLIFE Medical Labs, Edmonton, AB, Canada; Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada. Electronic address: victoria.higgins@dynalife.ca.
² Department of Laboratory Medicine, St. Michael's Hospital, Toronto, ON, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada; Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, ON, Canada.
³ Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada.
⁴ DynaLIFE Medical Labs, Edmonton, AB, Canada; Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada.
⁵ DynaLIFE Medical Labs, Edmonton, AB, Canada; Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada; Current Affiliation: LifeLabs, Toronto, ON, Canada.
⁶ DynaLIFE Medical Labs, Edmonton, AB, Canada; Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada. Electronic address: michelle.parker@dynalife.ca.

PMID: 37100108
DOI: 10.1016/j.clinbiochem.2023.04.006

Abstract

Objectives: Multiple sclerosis is diagnosed based on clinical and laboratory findings, including cerebrospinal fluid (CSF) oligoclonal banding (OCB) analysis. The lack of updated CSF OCB laboratory guidelines in Canada has likely led to variation in processes and reporting across clinical laboratories. As a first step to developing harmonized laboratory recommendations, we examined current CSF OCB processes, reporting, and interpretation across all Canadian clinical laboratories currently performing this test.

Design and methods: A survey of 39 questions was sent to clinical chemists at all 13 Canadian clinical laboratories performing CSF OCB analysis. The survey included questions regarding quality control processes, reporting practices for CSF gel electrophoresis pattern interpretation, and associated tests and calculated indices.

Results: The survey response rate was 100%. Most (10/13) laboratories use ≥2 CSF-specific bands (2017 McDonald Criteria) as their CSF OCB positivity cut-off and only 2/13 report the number of bands with every report. Most (8/13 and 9/13) laboratories report an inflammatory response pattern and monoclonal gammopathy pattern, respectively. However, the process for reporting and/or confirming a monoclonal gammopathy varies widely. Variation was observed for reference intervals, units, and the panel of reported associated tests and calculated indices. The maximum acceptable time interval between paired CSF and serum collections varied from 24 h to no limit.

Conclusions: Profound variation exists in processes, reporting, and interpretation of CSF OCB and associated tests and indices across Canadian clinical laboratories. Harmonization of CSF OCB analysis is required to ensure continuity and quality of patient care. Our detailed assessment of current practice variation highlights the need for clinical stakeholder engagement and further data analysis to support optimal interpretation and reporting practices, which will aid in developing harmonized laboratory recommendations.

Keywords: Cerebrospinal fluid; IgG index; Multiple sclerosis; Oligoclonal banding.

MeSH terms

Canada
Humans
Laboratories, Clinical
Monoclonal Gammopathy of Undetermined Significance*
Multiple Sclerosis* / cerebrospinal fluid
Multiple Sclerosis* / diagnosis
Oligoclonal Bands
Paraproteinemias*

Substances

Oligoclonal Bands