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Performance of a New Microfluidic Dengue NS1 Immuno-magnetic Agglutination Assay for the Rapid Diagnosis of Dengue Infection in Adults

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  • 1 Division of Infectious Diseases and Tropical Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
  • | 2 Division of Dengue Hemorrhagic Fever Research, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
  • | 3 Siriraj Center of Research Excellence in Dengue & Emerging Pathogens, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
  • | 4 Molecular Biology of Dengue and Flaviviruses Research Team, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency, Klong Luang, Pathumthani, Thailand;
  • | 5 Medical Department, Loei Provincial Hospital, Ministry of Health, Loei, Thailand

ABSTRACT.

Dengue (DENV) infections are a public health concern worldwide and thus early diagnosis is important to ensure appropriate clinical management. The rapid diagnostic test (RDT) targets nonstructural protein 1 (NS1) detection and is the main tool used for diagnostic purpose. In this study, we evaluated the performance of a new rapid and semi-quantitative microfluidic DENV NS1 immuno-magnetic agglutination assay or IMA (ViroTrack Dengue Acute, BluSense Diagnostics, Copenhagen, Denmark). We studied 233 subjects confirmed to have DENV infection (by a real-time reverse transcriptase polymerase chain reaction) and 200 control samples were taken from patients with confirmed diagnoses of other febrile illnesses, in Thailand. Samples were tested using the NS1 antigen (Ag) detection methods: in-house NS1 Ag ELISA (ELISA), SD BIOLINE Dengue NS1 Ag RDT (ICT), and ViroTrack Dengue Acute (IMA). Sensitivities of these tests were 86.3%, 78.9%, and 85.5%, respectively. All tests showed high specificity (100%, 99%, and 97% for ELISA, ICT, and IMA, respectively). The sensitivities of both RDTs were affected by the low sensitivity to DENV-2 and DENV-4. NS1 Ag was detected in every patient on day 1 and day 2 after onset of illness by ELISA and IMA with a decline in detection rates over time after day 6 of illness. NS1 detection rate using ICT decreased from 100% on day 1 of illness to 98.6% on day 2 after onset of illness. By day 6, the detection rate was 45.9%. Thus, IMA performed better than ICT for early and rapid diagnosis of DENV infections in endemic countries.

Author Notes

Address correspondence to Yupin Suputtamongkol, Department of Medicine, Faculty of Medicine Siriraj Hospital, 2 Wang Lang, Bangkok- noi, Bangkok 10700, Thailand. E-mail: ysuputtamongkol@gmail.com

Disclosure: The Ethical Committee at the Faculty Medicine Siriraj Hospital, Mahidol University, approved the study protocol (COA no: Si200/2019).

Authors’ addresses: Ekkarat Wongsawat, Yupin Suputtamongkol, Susan Assanasaen, Saowaluk Silpasakorn, Nasikarn Angkasekwinai, and Eakkawit Yamasmith, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand, E-mails: ewongsawat@gmail.com, ysuputtamongkol@gmail.com, susan.ass@mahidol.ac.th, saowaluksilpasakorn@gmail.com, nasikarn@gmail.com, and mike_th99@hotmail.com. Panisadee Avirutnan, Siriraj Center of Research Excellence in Dengue & Emerging Pathogens, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand, E-mail: panisadee.avi@mahidol.edu. Chunya Puttikhunt, Molecular Biology of Dengue and Flaviviruses Research Team, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency, Klong Luang, Pathumthani, Thailand, E-mail: chaunyapk@biotec.or.th.Tanapan Prommool, Molecular Biology of Dengue and Flaviviruses Research Team, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency, Klong Luang, Pathumthani, Thailand, E-mail: tanapan.pro@biotec.or.th. Kanigar Niwattayakul, Loei Hospital, Loei Province, Thailand, E-mail: janthira1817@gmail.com.

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