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. 2020 Mar 17;15(3):e0230337.
doi: 10.1371/journal.pone.0230337. eCollection 2020.

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  1 , Yvonne Winkelmann  2 , Latdamone Keoviengkhone  3 , Vatsana Sopraseuth  3 , Simone Kann  4 , Jessica Hansen  2 , Hussein El Halas  5 , Petra Emmerich  6   7 , Jonas Schmidt-Chanasit  8   9 , Herbert Schmitz  6 , Angela Mika  2 , Christina Deschermeier  2
Affiliations

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 et al. PLoS One. .

Abstract

Background: 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.

Methodology/principal findings: 92 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/significance: The 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.

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Conflict of interest statement

I have read the journal's policy and the authors of this manuscript have the following competing interests: HS and PE are inventors of patent EP2492689 owned by BNITM; HS, PE, and CD are inventors of patent EP3207375 owned by BNITM. HEH is an employee of Altona Diagnostics GmbH. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. SD Bioline Dengue Duo test results.
Acute phase serum samples from 92 patients with a PCR-confirmed DENV infection were analyzed with the SD Bioline Dengue Duo NS1 (A,D), IgM (B, D) and IgG test (C). Samples were stratified according to sampling day d (post onset of symptoms) and Ct-value (categories low (≤ 28.0), medium (28.0 < Ct ≤ 33.0), high (Ct > 33.0) indicated by dashed lines). Open/filled circles represent negative/positive results. Absolut sample numbers (n positives / N samples in category) and percentages are displayed. Statistically significant differences are indicated (*: p < 0.05, **: p < 0.01, ***: p < 0.001, ****: p < 0.0001).
Fig 2
Fig 2. SD Bioline Dengue Duo NS1 test results stratified according to anti-DENV IgG status.
Acute phase serum samples from 92 patients with a PCR-confirmed DENV infection were categorized according to their anti-DENV IgG status as defined by DENV IgG IIFT. (A) Tabular representation of subgroup characteristics. Ct: threshold cycle, dpo: days post onset of symptoms. (B) DENV IgG IIFT negative samples (N = 24), (C) DENV IgG IIFT positive samples (N = 68). Samples were stratified according to sampling day d (post onset of symptoms) and Ct-value (categories low (≤ 28.0), medium (28.0 < Ct ≤ 33.0), high (Ct > 33.0) indicated by dashed lines). Open/filled circles represent negative/positive NS1 test results. Absolut sample numbers (n positives / N samples in category) and percentages are displayed. ***: p < 0.001, ****: p < 0.0001.
Fig 3
Fig 3. Comparison of SD Bioline Dengue Duo test results with ELISA results and DENV IgG IIFT.
A subset of 74 acute phase serum samples (A) was analyzed with the Platelia NS1 Antigen ELISA (B), the Panbio DENV μ-capture ELISA (C) and the Panbio DENV IgG ELISA (D). Open/filled circles represent negative/positive results obtained with the corresponding SD Bioline Dengue Duo tests. Shaded areas represent index values rated as equivocal according to the respective manufacturer’s recommendations. (E) Tabular summary of results and statistical testing.
Fig 4
Fig 4. Seroconversion in DF patients detected by SD Bioline Dengue Duo IgM test and Panbio μ-capture ELISA.
For 35 patients (A) both an acute phase serum sample (S1) and a follow-up sample taken during the convalescent phase (S2) were analyzed (B). Open/filled circles represent samples tested negative/positive in the SD Bioline Dengue Duo IgM test. Shaded areas represent index values rated as equivocal according to the respective manufacturer’s recommendations. (C) Subset of sample pairs with a DENV IgG IIFT negative S1 sample, (D) Subset of sample pairs with a DENV IgG IIFT positive S1 sample. (E) Tabular summary of results. *: p < 0.05, ns: not significant.
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Funding was provided by the European Regional Development Fund (ERDF) (Europäischer Fonds für Regionale Entwicklung (EFRE), http://www.hamburg.de/efre/, project no. BWF/H/52228/2012/13.10.10-1/3.4; JB, YW, SK, JH, AM, CD). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. HEH is an employee of Altona Diagnostics GmbH. Altona Diagnostics GmbH provided support in the form of salary for HEH and research materials, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of this author are articulated in the “author contributions” section.