Dried blood spot improves global access to aquaporin-4-IgG testing for neuromyelitis optica.

IF 4.4 2区医学 Q1 CLINICAL NEUROLOGY

Annals of Clinical and Translational Neurology Pub Date : 2024-11-01 Epub Date: 2024-10-15 DOI:10.1002/acn3.52178

Nisa Vorasoot, Yahya J Abdulrahman, Farrah Mateen, James P Fryer, Vyanka Redenbaugh, Jessica A Sagen, Abdu K Musubire, Sarah M Jenkins, Amy P Gorsh, John J Chen, Anastasia Zekeridou, Andrew McKeon, Eoin P Flanagan, John R Mills, Sean J Pittock

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Abstract

Objective: This study aimed to evaluate the diagnostic accuracy of dried blood spot (DBS) compared with conventional serum Aquaporin-4-IgG (AQP4-IgG) testing.

Methods: Prospective multicenter diagnostic study was conducted between April 2018 and October 2023 across medical centers in the United States, Uganda, and the Republic of Guinea. Neuromyelitis optica spectrum disorder (NMOSD) patients and controls collected blood on filter paper cards along with concurrent serum samples. These samples underwent analysis using flow cytometric live-cell-based assays (CBA) and enzyme-linked immunosorbent assay (ELISA) to determine AQP4 serostatus. The accuracy of AQP4-IgG detection between DBS and serum (gold standard) was compared.

Results: Among 150 participants (47 cases, 103 controls), there was a strong correlation between DBS and serum samples (Spearman's correlation coefficient of 0.82). The AUC was 0.97 (95% CI: 0.92-0.99). AQP4-IgG detection through DBS showed 87.0% sensitivity (95% CI: 0.74-0.95) and 100% specificity (95% CI: 0.96-1.00) using CBA, and 65.2% sensitivity (95% CI: 0.43-0.84) and 95.2% specificity (95% CI: 0.76-0.99) using ELISA. Serum ELISA demonstrated 69.6% sensitivity (95% CI: 0.47-0.87) and 98.4% specificity (95% CI: 0.91-0.99). The stability of DBS in detecting AQP4-IgG persisted over 24 months for most cases.

Interpretation: The DBS represents a viable alternative for detecting AQP4-IgG in resource-limited settings to diagnose NMOSD, offering high sensitivity and specificity comparable to serum testing. Moreover, DBS has low shipping costs, is easy to administer, and is suitable for point-of-care testing.

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干血斑提高了全球神经脊髓炎视网膜病变水肿素-4-IgG 检测的可及性。

目的本研究旨在评估干血斑（DBS）与传统血清Aquaporin-4-IgG（AQP4-IgG）检测相比的诊断准确性：2018年4月至2023年10月期间，在美国、乌干达和几内亚共和国的医疗中心开展了前瞻性多中心诊断研究。神经脊髓炎视网膜频谱障碍（NMOSD）患者和对照组在滤纸卡上采集血液，同时采集血清样本。这些样本通过流式细胞活细胞检测法（CBA）和酶联免疫吸附法（ELISA）进行分析，以确定 AQP4 血清状态。比较了 DBS 和血清（金标准）检测 AQP4-IgG 的准确性：在 150 名参与者（47 名病例，103 名对照组）中，DBS 与血清样本之间存在很强的相关性（斯皮尔曼相关系数为 0.82）。AUC为0.97（95% CI：0.92-0.99）。使用 CBA 通过 DBS 检测 AQP4-IgG 的灵敏度为 87.0%（95% CI：0.74-0.95），特异度为 100%（95% CI：0.96-1.00）；使用 ELISA 的灵敏度为 65.2%（95% CI：0.43-0.84），特异度为 95.2%（95% CI：0.76-0.99）。血清 ELISA 的灵敏度为 69.6%（95% CI：0.47-0.87），特异度为 98.4%（95% CI：0.91-0.99）。在大多数病例中，DBS 检测 AQP4-IgG 的稳定性持续了 24 个月：在资源有限的环境中，DBS是检测AQP4-IgG以诊断NMOSD的可行替代方法，其灵敏度和特异性均可媲美血清检测。此外，DBS 的运输成本较低，易于管理，适合进行床旁检测。

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来源期刊

Annals of Clinical and Translational Neurology Medicine-Neurology (clinical)

CiteScore

9.10

自引率

1.90%

发文量

218

审稿时长

8 weeks

期刊介绍： Annals of Clinical and Translational Neurology is a peer-reviewed journal for rapid dissemination of high-quality research related to all areas of neurology. The journal publishes original research and scholarly reviews focused on the mechanisms and treatments of diseases of the nervous system; high-impact topics in neurologic education; and other topics of interest to the clinical neuroscience community.