基于葡萄糖醛酸甘露聚糖单克隆抗体 18B7 的室内免疫层析测试对临床疑似隐球菌病的诊断性能:泰国北部大规模原型评估。

IF 3.6 3区 生物学 Q2 MYCOLOGY Mycopathologia Pub Date : 2024-08-09 DOI:10.1007/s11046-024-00882-x
Kritsada Pruksaphon, Artid Amsri, Patcharin Thammasit, Joshua D Nosanchuk, Pisinee Aiumurai, Sirida Youngchim
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引用次数: 0

摘要

目的:在泰国,隐球菌病主要表现为脑膜脑炎。早期快速诊断对于降低隐球菌脑膜炎的死亡率和发病率至关重要。我们的目标是确定和确立基准商用诊断试剂盒(CrAg® LFA)与基于单克隆抗体(MAb)18B7 的廉价内部免疫层析检验(ICT)大规模原型之间的诊断性能:我们开发了大规模隐球菌多糖抗原快速检测原型,该原型采用了单抗夹心ICT形式,使用了对新型隐球菌葡萄糖醛酸氧甘露聚糖(GXM)抗原具有高度特异性的MAb 18B7。内部 MAb18B7 ICT 是在国际标准化组织 (ISO) 13485 的控制下按照行业标准生产的:内部 MAb18B7 ICT 的诊断灵敏度、特异性和准确性分别为 99.10%、97.61% 和 97.83%。根据对泰国北部 580 例临床疑似隐球菌病患者标本的回顾性评估,一致性卡帕(κ)系数为 0.968:数据表明,这种内部 MAb 18B7 ICT 对解决泰国的隐球菌感染问题大有裨益。此外,预计这种廉价的信息和通信技术将在各种全球战略中发挥关键作用,这些战略旨在到 2030 年根除艾滋病毒感染者中的隐球菌脑膜炎。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Diagnostic Performances of an in-House Immunochromatography Test Based on the Monoclonal Antibody 18B7 to Glucuronoxylomannan for Clinical Suspected Cryptococcosis: a Large-Scale Prototype Evaluation in Northern Thailand.

Objective: Cryptococcosis predominantly presents as a meningoencephalitis in Thailand. Early and expeditious diagnosis is essential for reducing both mortality and morbidity associated with cryptococcal meningitis. We aim to define and establish the diagnostic performances between the benchmark commercially available diagnostic kit (CrAg® LFA) and the large-scale prototype of an inexpensive in-house immunochromatographic test (ICT) based on monoclonal antibody (MAb) 18B7.

Methods: We have developed the large-scale prototype for the rapid detection of cryptococcal polysaccharide antigens by utilizing a single antibody sandwich ICT format employing MAb 18B7, which is highly specific to Cryptococcus neoformans glucuronoxylomannan (GXM) antigens. An in-house MAb18B7 ICT was manufactured in accordance with industry standards under the control of the International Organization for Standardization (ISO) 13485.

Results: The diagnostic sensitivity, specificity, and accuracy for the in-house MAb 18B7 ICT were 99.10%, 97.61%, and 97.83%, respectively. The agreement kappa (κ) coefficient was 0.968 based on the retrospective evaluation of 580 specimens from patients living in northern Thailand with clinically suspected cryptococcosis.

Conclusion: The data suggest that this in-house MAb 18B7 ICT will be highly beneficial for addressing the issue of cryptococcal infection in Thailand. Moreover, it is anticipated that this inexpensive ICT can play a pivotal role in various global strategies aimed at eradicating cryptococcal meningitis among individuals living with HIV by 2030.

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来源期刊
Mycopathologia
Mycopathologia 生物-真菌学
CiteScore
6.80
自引率
3.60%
发文量
76
审稿时长
3 months
期刊介绍: Mycopathologia is an official journal of the International Union of Microbiological Societies (IUMS). Mycopathologia was founded in 1938 with the mission to ‘diffuse the understanding of fungal diseases in man and animals among mycologists’. Many of the milestones discoveries in the field of medical mycology have been communicated through the pages of this journal. Mycopathologia covers a diverse, interdisciplinary range of topics that is unique in breadth and depth. The journal publishes peer-reviewed, original articles highlighting important developments concerning medically important fungi and fungal diseases. The journal highlights important developments in fungal systematics and taxonomy, laboratory diagnosis of fungal infections, antifungal drugs, clinical presentation and treatment, and epidemiology of fungal diseases globally. Timely opinion articles, mini-reviews, and other communications are usually invited at the discretion of the editorial board. Unique case reports highlighting unprecedented progress in the diagnosis and treatment of fungal infections, are published in every issue of the journal. MycopathologiaIMAGE is another regular feature for a brief clinical report of potential interest to a mixed audience of physicians and laboratory scientists. MycopathologiaGENOME is designed for the rapid publication of new genomes of human and animal pathogenic fungi using a checklist-based, standardized format.
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