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

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

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 det...

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Main Authors: 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
Format: Article
Language:English
Published: MDPI AG 2025-01-01
Series:Viruses
Subjects:
dengue virus
NS1
antigen
chemiluminescence immunoassay
Online Access:https://www.mdpi.com/1999-4915/17/1/106
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Summary: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.
ISSN:1999-4915

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