Performance of Two Commercial Dengue NS1 Rapid Tests for the Diagnosis of Adult Patients with Dengue Infection

Ekkarat Wongsawat; Panisadee Avirutnan; Yoon-Won Kim; Yupin Suputtamongkol

doi:10.33192/Smj.2020.10

Authors

Ekkarat Wongsawat Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700 http://orcid.org/0000-0001-7624-9150
Panisadee Avirutnan Department of Research and Development, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700 http://orcid.org/0000-0003-0053-3045
Yoon-Won Kim Department of Microbiology, College of Medicine, Hallym University, Chuncheon http://orcid.org/0000-0002-2242-2664
Yupin Suputtamongkol Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700 http://orcid.org/0000-0001-7324-1698

DOI:

https://doi.org/10.33192/Smj.2020.10

Keywords:

Dengue infection; nonstructural protein -1; adult patients; rapid detection test

Abstract

Objective: To determine the diagnostic performance of two commercially available dengue NS1 antigen rapid detection tests (RDTs); namely the SD BIOLINE Dengue NS1 RDT and the ImmuneMed Dengue NS1 Rapid, for the diagnosis of adult patients with dengue infection.
Methods: The study was performed by using archived samples from 237 patients with the laboratory-confirmed dengue infection. Archived, well-characterized samples from an additional 208 febrile individuals from Thailand were used as the control group. Reference testing to confirm the diagnosis in dengue patients included RT-PCR and in-house NS1 ELISA, in-house IgM and IgG capture ELISAs.
Results: The sensitivity of the SD BIOLINE Dengue NS1 RDT was 100%, and the specificity was 99% (95%CI 96.6 to 99.7%). False positive was found in 2 samples from patient with scrub typhus. The sensitivity and specificity of the ImmuneMed Dengue NS1 Ag Rapid were 97.4% (95% CI, 95.5 to 99.5%) and 96.6% (95%CI 93.5 to 98.4%) respectively. False positive results were found in 7 patients with murine typhus, scrub typhus, and influenza.
Conclusion: Both RDTs showed comparable sensitivity and specificity in this study population. Data from this study could be used to facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks.

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