Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus.

IF 3.8 3区医学 Q2 VIROLOGY

Viruses-Basel Pub Date : 2025-01-14 DOI:10.3390/v17010106

Bo Peng, Zhonggang Fang, Cong Li, Kun Liu, Ting Wang, Ke Huang, Fan Yang, Yalan Huang, Chunli Wu, Yue Li, Dana Huang, Qian Zhang, Yijun Tang, Xiaolian Liu, Wei Rao, Xiaolu Shi

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引用次数: 0

Abstract

Aims: The screening and diagnosis of dengue virus infection play a crucial role in controlling the epidemic of dengue fever, highlighting the urgent need for a highly sensitive, simple, and rapid laboratory testing method. This study aims to assess the clinical performance of MAGLUMI Denv NS1 in detecting dengue virus NS1 antigen.

Methods: A retrospective study was conducted to assess the sensitivity and specificity of MAGLUMI Denv NS1 using residual samples. Dengue-confirmed and excluded samples, validated by qPCR, were subjected to testing with MAGLUMI Denv NS1 in accordance with the manufacturer's instructions. The linear range, endogenous interference, and cross-reactivity of MAGLUMI Denv NS1 were verified, and a consistency analysis with commercial comparator products was carried out.

Results: The diagnostic specificity of MAGLUMI Denv NS1 is 98.41% (62/63), and the sensitivity is 98.32% (117/119). It effectively detects various serotypes of dengue virus, with no observed endogenous interference or cross-reactivity. Additionally, the consistency of NS1, IgM, and IgG tests on the MAGLUMI platform compared to commercial comparator reagents reaches 85.71%, 99.25%, and 98.97%, respectively.

Conclusions: The MAGLUMI Denv NS1 represents a highly sensitive laboratory testing method capable of enhancing the diagnostic accuracy and efficiency of dengue virus infection detection.

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来源期刊

Viruses-Basel VIROLOGY-

CiteScore

7.30

自引率

12.80%

发文量

2445

审稿时长

1 months

期刊介绍： Viruses (ISSN 1999-4915) is an open access journal which provides an advanced forum for studies of viruses. It publishes reviews, regular research papers, communications, conference reports and short notes. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced. We also encourage the publication of timely reviews and commentaries on topics of interest to the virology community and feature highlights from the virology literature in the ''News and Views'' section. Electronic files or software regarding the full details of the calculation and experimental procedure, if unable to be published in a normal way, can be deposited as supplementary material.