Abstract
Dengue is an increasing public health concern worldwide and requires efficient laboratory diagnostics. We evaluated three commercially available dengue rapid diagnostic tests—the Humasis Dengue Combo NS1 & IgG/IgM (Humasis, Korea), SD Bioline Dengue Duo NS1 Ag & IgG/IgM (SD Bioline, Korea), and CareUS Dengue Combo NS1 and IgM/IgG kits (WellsBio, Korea)—and compared them to reference immunoglobulin M (IgM) or immunoglobulin G (IgG) ELISAs and quantitative reverse transcription polymerase chain reaction (qRT-PCR) assays. In total, 109 dengue-positive samples from children with acute symptomatic dengue and 63 dengue-negative samples from febrile and asymptomatic individuals were collected. For the nonstructural 1 protein (NS1) Ag test, the sensitivity and specificity were in the following order: CareUS (79.82 and 100%), Humasis (63.30 and 100%), and SD Bioline (48.62 and 100%). For IgM and IgG, CareUS had the highest sensitivities and specificities (89.91 and 100%; 82.57 and 100%, respectively), followed by SD Bioline (60.55 and 100%, 77.98 and 100%, respectively), and Humasis (51.38 and 98.21%, 72.48 and 95.24%, respectively). The IgM kits were more sensitive than the NS1 Ag or IgG kits; however, combining NS1 Ag and IgM reduced the number of missed cases. Therefore, the NS1 Ag plus IgM dengue kits increase the accuracy of the results. In our study, the CareUS Dengue Combo NS1 and IgM/IgG kit showed higher accuracy in performance with reference to qRT-PCR and ELISA results.
Highlights
Dengue fever is caused by four serotypes of dengue virus (DENV)—DENV1, DENV2, DENV3, and DENV4—and is transmitted mainly by Aedes aegypti
The serum panel consisted of 172 serum samples, including 102 cases confirmed to be positive for DENV infection by qRT-PCR and 7 cases confirmed to be positive for DENV infection based on immunoglobulin M (IgM) or IgM/immunoglobulin G (IgG) ELISAs
The panel included 63 serum samples collected from patients with other illnesses that tested negative for DENV by qRT-PCR, or who tested negative for dengue by IgM and IgG ELISAs
Summary
Dengue fever is caused by four serotypes of dengue virus (DENV)—DENV1, DENV2, DENV3, and DENV4—and is transmitted mainly by Aedes aegypti. Dengue rapid diagnostic test (anti-dengue IgM/ IgG RDT) kits yield results in less than 15 min, are simple to perform and, are used widely as a point-of-care test in outpatient clinics and emergency departments [11]. These kits are designed to detect the presence of anti-dengue IgM or IgG antibodies in the blood of patients with dengue. The evaluations were performed using existing qRT-PCR- and IgM/IgG ELISA-based diagnostic tests as references
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