迈瑞诊断测试用于登革病毒自动检测的临床性能
Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus.
作者信息
Peng Bo, Fang Zhonggang, Li Cong, Liu Kun, Wang Ting, Huang Ke, Yang Fan, Huang Yalan, Wu Chunli, Li Yue, Huang Dana, Zhang Qian, Tang Yijun, Liu Xiaolian, Rao Wei, Shi Xiaolu
机构信息
Microbiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, China.
Key-Laboratory of Intelligent Tracking and Forecasting for Infectious Disease, NHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
出版信息
Viruses. 2025 Jan 14;17(1):106. doi: 10.3390/v17010106.
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.
目的
登革热病毒感染的筛查与诊断在控制登革热疫情中起着关键作用，凸显了对一种高灵敏度、简单且快速的实验室检测方法的迫切需求。本研究旨在评估迈瑞登革热NS1检测试剂在检测登革热病毒NS1抗原方面的临床性能。
方法
采用回顾性研究，使用剩余样本评估迈瑞登革热NS1检测试剂的灵敏度和特异性。经实时荧光定量聚合酶链反应（qPCR）验证的登革热确诊和排除样本，按照制造商说明用迈瑞登革热NS1检测试剂进行检测。验证迈瑞登革热NS1检测试剂的线性范围、内源性干扰和交叉反应性，并与商业对照产品进行一致性分析。
结果
迈瑞登革热NS1检测试剂的诊断特异性为98.41%（62/63），灵敏度为98.32%（117/119）。它能有效检测登革热病毒的各种血清型，未观察到内源性干扰或交叉反应性。此外，与商业对照试剂相比，迈瑞平台上NS1、IgM和IgG检测的一致性分别达到85.71%、99.25%和98.97%。
结论
迈瑞登革热NS1检测试剂是一种高灵敏度的实验室检测方法，能够提高登革热病毒感染检测的诊断准确性和效率。
Zotero 插件