Department of Clinical Biochemistry, Manchester University NHS Foundation Trust, Manchester, UK.
The Neuroscience Laboratories, The Walton Centre NHS Foundation Trust, Liverpool, UK.
Ann Clin Biochem. 2023 Sep;60(5):353-355. doi: 10.1177/00045632231179618. Epub 2023 Jun 5.
Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system. Diagnosis is based on the 2017 revised McDonald criteria. Unmatched oligoclonal bands (OCB) within the CSF (i.e. positive OCB) can substitute for dissemination in time by magnetic resonance imaging (MRI). Simonsen et al. (2020) claimed a raised (>0.7) immunoglobulin G (IgG) index could replace OCB status. This study aimed to establish the diagnostic utility of IgG index for MS in the population served by The Walton Centre NHS Foundation Trust (WCFT) a neurology and neurosurgery hospital, and to derive a population-based IgG index reference interval.
OCB results from the laboratory information system (LIS) were collated from November 2018 to 2021. Final diagnosis and medication history was obtained from the electronic patient record. Exclusions were made based on age (<18 years) at the time of lumbar puncture (LP) disease-modifying treatment prior to LP, unknown IgG index and unclear OCB patterns.
935 of 1101 results remained following exclusions. 226 (24.2%) had a diagnosis of MS, 212 (93.8%) were OCB positive and 165 (73.0%) had a raised IgG index. The diagnostic specificity of a raised IgG index was calculated at 90.3% compared to 86.9% for positive OCB. 386 results with negative OCB were used to establish the IgG index reference interval (0.36-0.68) at 95th percentiles.
This study provides evidence that IgG index should not replace OCB in the diagnosis of MS. >0.7 is an appropriate cut-off to define a raised IgG index for the patient population.
多发性硬化症（MS）是一种中枢神经系统的慢性脱髓鞘疾病。诊断基于 2017 年修订的 McDonald 标准。脑脊液中未匹配的寡克隆带（OCB）（即阳性 OCB）可以替代磁共振成像（MRI）的时间传播。Simonsen 等人（2020 年）声称升高的（>0.7）免疫球蛋白 G（IgG）指数可以替代 OCB 状态。本研究旨在确定 IgG 指数在为 Walton 中心国民保健信托基金会（WCFT）服务的人群中对 MS 的诊断效用，WCFT 是一家神经病学和神经外科医院，并得出基于人群的 IgG 指数参考区间。
从实验室信息系统（LIS）中整理出 2018 年 11 月至 2021 年的 OCB 结果。从电子患者记录中获取最终诊断和药物治疗史。排除的标准是腰椎穿刺（LP）时的年龄（<18 岁）、LP 前的疾病修正治疗、未知的 IgG 指数和不明确的 OCB 模式。
排除后有 935 项结果仍保留。226 项（24.2%）诊断为 MS，212 项（93.8%）为 OCB 阳性，165 项（73.0%）有升高的 IgG 指数。与阳性 OCB 相比，升高的 IgG 指数的诊断特异性计算为 90.3%。386 项阴性 OCB 结果用于建立 IgG 指数参考区间（95%上限为 0.36-0.68）。
本研究提供了证据表明，在 MS 的诊断中，IgG 指数不应替代 OCB。>0.7 是定义患者人群中升高的 IgG 指数的适当截止值。
