Assessment of diagnostic and analytic performance of the SD Bioline Dengue Duo test for dengue virus (DENV) infections in an endemic area (Savannakhet province, Lao People's Democratic Republic).

Jörg Blessmann,Jessica Hansen,Christina Deschermeier,Yvonne Winkelmann,Angela Mika,Latdamone Keoviengkhone,Jonas Schmidt-Chanasit,Simone Kann,Hussein El Halas,Petra Emmerich,Vatsana Sopraseuth,Herbert Schmitz

doi:10.1371/journal.pone.0230337

Abstract

BackgroundRapid tests detecting both dengue virus (DENV) NS1 antigen and anti-DENV IgM and IgG antibodies facilitate diagnosis of dengue fever (DF) in resource-poor settings.Methodology/principal findings92 acute phase serum samples from patients with a PCR-confirmed DENV infection collected in Lao People’s Democratic Republic (Lao PDR) in 2013 and 2015 were analyzed with the SD Bioline Dengue Duo test. A subset of 74 samples was additionally tested with the Platelia NS1 antigen test, the Panbio DENV μ-capture ELISA and the Panbio DENV IgG ELISA. IgM seroconversion was assayed using follow-up samples of 35 patients collected in the convalescent phase. 57.6%, 22.8% and 44.6% of acute phase serum samples tested positive in the SD Bioline Dengue Duo NS1, IgM, and IgG test, respectively. Diagnostic sensitivity of the SD Bioline Dengue Duo NS1 test strongly correlated with viral load, decreased rapidly over the acute phase of the disease, and was significantly reduced in presence of high anti-DENV IgG antibody titers resulting from secondary DENV infection. While a good concordance (Cohen’s kappa 0.78) was found between the SD Bioline Dengue Duo NS1 test and the Platelia NS1 antigen ELISA, both the SD Bioline Dengue Duo IgM and IgG test displayed a significantly lower sensitivity than the corresponding ELISA tests.Conclusions/significanceThe SD Bioline Dengue Duo test is a valuable tool for diagnosis of DENV infections especially when analyzing early acute phase samples with high viral load. Nevertheless, in endemic areas, where secondary flavivirus infections are common, diagnostic sensitivity of the NS1 and IgM test components may be compromised.

Highlights

With an estimated incidence of 100 million clinically apparent cases per year in Asia, Latin America and Africa, dengue fever is the most frequent arboviral disease globally [1]
Diagnostic sensitivity of the SD Bioline Dengue Duo NS1 antigen test depends on viral load and decreases rapidly over the acute phase of the disease
We describe the diagnostic performance of the SD Bioline Dengue Duo rapid test in comparison to commercial ELISA kits (PLATELIATM Dengue NS1 Ag ELISA, Panbio1 Dengue IgM Capture ELISA, Panbio1 Dengue IgG Indirect ELISA) and an in-house dengue virus (DENV) IgG indirect immunofluorescence test (IIFT) in an endemic setting (Savannakhet province, Lao People’s Democratic Republic (Lao PDR))

Summary

Introduction

With an estimated incidence of 100 million clinically apparent cases per year in Asia, Latin America and Africa, dengue fever is the most frequent arboviral disease globally [1]. In an estimated 25% of infected individuals, a sudden onset of high-grade fever occurs after an incubation period of 4–7 days, often accompanied by other unspecific disease symptoms like headache, myalgia, arthralgia, nausea, vomiting, and rash. During this febrile phase, leucopenia and thrombocytopenia are frequently observed; this finding (as the occurrence of petechiae and/or a positive tourniquet test) can support differentiation of DF from other febrile illnesses [3]. Some patients develop severe symptoms caused by increased vascular permeability, plasma leakage and intravascular volume depletion that can be lethal if left untreated Rapid tests detecting both dengue virus (DENV) NS1 antigen and anti-DENV IgM and IgG antibodies facilitate diagnosis of dengue fever (DF) in resource-poor settings

Methods

Results

Conclusion