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自身抗体发现、检测方法开发与应用:死亡谷、生存之海及其他。

Autoantibody Discovery, Assay Development and Adoption: Death Valley, the Sea of Survival and Beyond.

机构信息

Department of Medicine, Cumming School of Medicine, Calgary, AB, Canada.

Department of Clinical Nursing, School of Health Sciences, University of Occupational and Environmental Health, Kitakyushu, Japan.

出版信息

Front Immunol. 2021 May 27;12:679613. doi: 10.3389/fimmu.2021.679613. eCollection 2021.

Abstract

Dating to the discovery of the Lupus Erythematosus (LE) cell in 1948, there has been a dramatic growth in the discovery of unique autoantibodies and their cognate targets, all of which has led to the availability and use of autoantibody testing for a broad spectrum of autoimmune diseases. Most studies of the sensitivity, specificity, commutability, and harmonization of autoantibody testing have focused on widely available, commercially developed and agency-certified autoantibody kits. However, this is only a small part of the spectrum of autoantibody tests that are provided through laboratories world-wide. This manuscript will review the wider spectrum of testing by exploring the innovation pathway that begins with autoantibody discovery followed by assessment of clinical relevance, accuracy, validation, and then consideration of regulatory requirements as an approved diagnostic test. Some tests are offered as "Research Use Only (RUO)", some as "Laboratory Developed Tests (LDT)", some enter Health Technology Assessment (HTA) pathways, while others are relegated to a "death valley" of autoantibody discovery and become "orphan" autoantibodies. Those that achieve regulatory approval are further threatened by the business world's "Darwinian Sea of Survival". As one example of the trappings of autoantibody progression or failure, it is reported that more than 200 different autoantibodies have been described in systemic lupus erythematosus (SLE), a small handful (~10%) of these have achieved regulatory approval and are widely available as commercial diagnostic kits, while a few others may be available as RUO or LDT assays. However, the vast majority (90%) are orphaned and languish in an autoantibody 'death valley'. This review proposes that it is important to keep an inventory of these "orphan autoantibodies" in 'death valley' because, with the increasing availability of multi-analyte arrays and artificial intelligence (MAAI), some can be rescued to achieve a useful role in clinical diagnostic especially in light of patient stratification and precision medicine.

摘要

自 1948 年发现红斑狼疮(LE)细胞以来,独特的自身抗体及其同源靶标的发现呈显著增长态势,这使得广泛的自身免疫性疾病都能够进行自身抗体检测。大多数关于自身抗体检测的敏感性、特异性、互换性和协调性的研究都集中在广泛可用、商业化开发和机构认证的自身抗体试剂盒上。然而,这只是全球实验室提供的自身抗体检测谱中的一小部分。本文将通过探索从自身抗体发现开始的创新途径,回顾更广泛的检测范围,随后评估临床相关性、准确性、验证,然后考虑作为批准诊断测试的监管要求。有些测试作为“仅供研究使用(RUO)”提供,有些作为“实验室开发测试(LDT)”提供,有些进入健康技术评估(HTA)途径,而其他则被归入自身抗体发现的“死亡谷”,成为“孤儿”自身抗体。那些获得监管批准的测试进一步受到商业世界“达尔文生存海洋”的威胁。作为自身抗体进展或失败的陷阱之一,据报道,在系统性红斑狼疮(SLE)中已经描述了 200 多种不同的自身抗体,其中只有少数(~10%)获得了监管批准,并作为商业诊断试剂盒广泛可用,而其他一些可能作为 RUO 或 LDT 检测提供。然而,绝大多数(90%)是孤儿,在自身抗体的“死亡谷”中奄奄一息。这篇综述认为,重要的是要保留这些“孤儿自身抗体”在“死亡谷”中的库存,因为随着多分析物阵列和人工智能(MAAI)的日益普及,一些自身抗体可以被挽救,以在临床诊断中发挥有用作用,特别是考虑到患者分层和精准医学。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e78f/8191456/250afefde857/fimmu-12-679613-g001.jpg

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