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一种新型的高通量快速筛选试验,用于检测 HTLV-I/II 感染患者体内的总 HTLV-I 和 HTLV-II 抗体。

A novel high-performance rapid screening test for the detection of total HTLV-I and HTLV-II antibodies in HTLV-I/II infected patients.

机构信息

Department of Research and Development, MP Biomedicals Asia Pacific Pte Ltd, Singapore, Singapore.

Laboratoire de Virologie Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix, Paris, France.

出版信息

BMC Infect Dis. 2024 Aug 26;24(1):860. doi: 10.1186/s12879-024-09791-2.

DOI:10.1186/s12879-024-09791-2
PMID:39187753
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11346188/
Abstract

Rapid diagnosis of human T-cell lymphotropic virus (HTLV) type-I and -II infections are essential for timely and cost-effective disease interventions. MP Diagnostics ASSURE HTLV-I/II Rapid Test was developed for the rapid detection of anti-HTLV-I/II antibodies in patients' serum, plasma, and whole blood specimens. ASSURE HTLV-I/II Rapid Test employed MP Biomedicals' proprietary HTLV-I/II Trifusion recombinant antigen conjugated with gold nanoparticles and HTLV-I / HTLV-II recombinant antigens immobilized on the nitrocellulose membrane to detect total HTLV-I and HTLV-II antibodies. The overall performance of the ASSURE HTLV-I/II Rapid Test was found to be 99.42% sensitivity (95% Confidence Interval, 98.32-99.88%) and 100% specificity (95% Confidence Interval, 99.58-100.00%) in the tested clinical samples, including a total of 518 HTLV-I/II positive specimens (396 HTLV-I infection, 97 HTLV-II infection and 25 HTLV-I/II dual infection) and 872 HTLV negative clinical specimens consisting of 691 healthy donor samples, 116 potentially cross-reactive samples, and 65 samples with interfering substances. The ASSURE HTLV-I/II Rapid Test can effectively be deployed as a screening tool in any prevalence studies, blood banks or organ transplant centres.

摘要

快速诊断人类 T 细胞嗜淋巴细胞病毒 (HTLV) 型-I 和 -II 感染对于及时和具有成本效益的疾病干预至关重要。MP 诊断公司的 ASSURE HTLV-I/II 快速检测试剂盒用于快速检测患者血清、血浆和全血样本中的抗-HTLV-I/II 抗体。ASSURE HTLV-I/II 快速检测试剂盒采用 MP 生物医学公司专有的 HTLV-I/II Trifusion 重组抗原与金纳米颗粒偶联,并将 HTLV-I/HTLV-II 重组抗原固定在硝酸纤维素膜上,以检测总 HTLV-I 和 HTLV-II 抗体。在测试的临床样本中,ASSURE HTLV-I/II 快速检测试剂盒的整体性能为 99.42%的灵敏度(95%置信区间,98.32-99.88%)和 100%的特异性(95%置信区间,99.58-100.00%),包括总共 518 份 HTLV-I/II 阳性样本(396 份 HTLV-I 感染、97 份 HTLV-II 感染和 25 份 HTLV-I/II 双重感染)和 872 份 HTLV 阴性临床样本,其中包括 691 份健康供体样本、116 份潜在交叉反应性样本和 65 份有干扰物质的样本。ASSURE HTLV-I/II 快速检测试剂盒可有效用作任何流行率研究、血库或器官移植中心的筛查工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c74a/11346188/ffcee21cc3b6/12879_2024_9791_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c74a/11346188/265cea652a49/12879_2024_9791_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c74a/11346188/ffcee21cc3b6/12879_2024_9791_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c74a/11346188/265cea652a49/12879_2024_9791_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c74a/11346188/ffcee21cc3b6/12879_2024_9791_Fig2_HTML.jpg

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