A sandwich chemiluminescent magnetic microparticle immunoassay for cryptococcal antigen detection.

IF 3.9 3区医学 Q1 PATHOLOGY Expert Review of Molecular Diagnostics Pub Date : 2024-06-01 Epub Date: 2024-06-19 DOI:10.1080/14737159.2024.2369243

Junpu Li, Yan Guo

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Abstract

Background: Cryptococcosis is a global invasive mycosis associated with significant morbidity and mortality. Cryptococcal antigen (CrAg) testing from serum and cerebrospinal fluid (CSF) has been regarded as a gold standard for early diagnosis. This study aimed to develop and validate a rapid and sensitive sandwich chemiluminescent magnetic microparticle immunoassay (CMIA) for quantitative detection of CrAg in sera.

Research design and methods: CMIA is based on magnetic beads modified with capture antibodies and biotinylated antibodies and Streptavidin-polyHRP, where biotinylated antibodies functioned as the recognition element and Streptavidin-polyHRP as the signal component. Assay parameters were first optimized, and then assay performances were evaluated.

Results: Under optimized conditions, the total runtime of the CMIA was 22 min. The assay had a wide linear range (2 -10,000 ng/mL) and high analytical sensitivity (0.24 ng/mL), together with acceptable reproducibility, accuracy, and stability. Besides, it exhibited no cross-reactivity with other pathogens. Importantly, the assay showed 92.91% (95% CI, 80.97-93.02%) overall qualitative agreement with a commercial ELISA kit in a retrospective cohort of 55 cases with confirmed cryptococcal infection, and 72 controls without evidence of invasive fungal disease (IFD).

Conclusion: These results demonstrated that the present study paved a novel strategy for reliable quantitative detection of CrAg in sera.

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用于检测隐球菌抗原的夹心化学发光磁性微粒免疫分析法。

背景：隐球菌病是一种全球性侵袭性真菌病，发病率和死亡率都很高。从血清和脑脊液（CSF）中检测隐球菌抗原（CrAg）一直被视为早期诊断的金标准。本研究旨在开发和验证一种快速、灵敏的夹心化学发光磁性微粒免疫分析法（CMIA），用于定量检测血清中的 CrAg：夹心化学发光磁性微粒免疫分析法是基于捕获抗体和生物素化抗体修饰的磁珠以及聚磷酸链霉亲和素，其中生物素化抗体作为识别元件，聚磷酸链霉亲和素作为信号元件。首先对测定参数进行了优化，然后对测定性能进行了评估：结果：在优化条件下，CMIA 的总运行时间为 22 分钟。该测定的线性范围宽（2 -10,000 ng/mL），分析灵敏度高（0.24 ng/mL），重现性、准确性和稳定性均可接受。此外，它与其他病原体没有交叉反应。重要的是，在55例确诊隐球菌感染病例和72例无侵袭性真菌病（IFD）证据的对照组的回顾性队列中，该检测方法与商业ELISA试剂盒的总体定性一致率为92.91%（95% CI，80.97-93.02%）：这些结果表明，本研究为血清中 CrAg 的可靠定量检测提供了一种新策略。

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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来源期刊

Expert Review of Molecular Diagnostics 医学-病理学

CiteScore

6.60

自引率

0.00%

发文量

审稿时长

1 months

期刊介绍： Expert Review of Molecular Diagnostics (ISSN 1473-7159) publishes expert reviews of the latest advancements in the field of molecular diagnostics including the detection and monitoring of the molecular causes of disease that are being translated into groundbreaking diagnostic and prognostic technologies to be used in the clinical diagnostic setting. Each issue of Expert Review of Molecular Diagnostics contains leading reviews on current and emerging topics relating to molecular diagnostics, subject to a rigorous peer review process; editorials discussing contentious issues in the field; diagnostic profiles featuring independent, expert evaluations of diagnostic tests; meeting reports of recent molecular diagnostics conferences and key paper evaluations featuring assessments of significant, recently published articles from specialists in molecular diagnostic therapy. Expert Review of Molecular Diagnostics provides the forum for reporting the critical advances being made in this ever-expanding field, as well as the major challenges ahead in their clinical implementation. The journal delivers this information in concise, at-a-glance article formats: invaluable to a time-constrained community.