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)

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2020 Mar 18

PMID 32182271

Citations 7

Authors

Jorg Blessmann

Yvonne Winkelmann

Latdamone Keoviengkhone

Vatsana Sopraseuth

Simone Kann

Jessica Hansen

Hussein El Halas

Petra Emmerich

Jonas Schmidt-Chanasit

Herbert Schmitz

Angela Mika

Christina Deschermeier

Affiliations

Soon will be listed here.

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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References

Pokriefka R, Manzor O, Markowitz N, Saravolatz L, Kvale P, Donovan R . Increased detection of human immunodeficiency virus antigenemia after dissociation of immune complexes at low pH. J Clin Microbiol. 1993; 31(6):1656-8. PMC: 265601. DOI: 10.1128/jcm.31.6.1656-1658.1993. View

Kikuti M, Cruz J, Rodrigues M, Tavares A, Paploski I, Silva M . Accuracy of the SD BIOLINE Dengue Duo for rapid point-of-care diagnosis of dengue. PLoS One. 2019; 14(3):e0213301. PMC: 6402663. DOI: 10.1371/journal.pone.0213301. View

Muller D, Depelsenaire A, Young P . Clinical and Laboratory Diagnosis of Dengue Virus Infection. J Infect Dis. 2017; 215(suppl_2):S89-S95. DOI: 10.1093/infdis/jiw649. View

Schupbach J, Flepp M, Pontelli D, Tomasik Z, Luthy R, Boni J . Heat-mediated immune complex dissociation and enzyme-linked immunosorbent assay signal amplification render p24 antigen detection in plasma as sensitive as HIV-1 RNA detection by polymerase chain reaction. AIDS. 1996; 10(10):1085-90. View

Lima M, Nogueira R, de Filippis A, Nunes P, Sousa C, da Silva M . A simple heat dissociation method increases significantly the ELISA detection sensitivity of the nonstructural-1 glycoprotein in patients infected with DENV type-4. J Virol Methods. 2014; 204:105-8. DOI: 10.1016/j.jviromet.2014.02.031. View

Dejnirattisai W, Jumnainsong A, Onsirisakul N, Fitton P, Vasanawathana S, Limpitikul W . Cross-reacting antibodies enhance dengue virus infection in humans. Science. 2010; 328(5979):745-8. PMC: 3837288. DOI: 10.1126/science.1185181. View

Bandyopadhyay S, Lum L, Kroeger A . Classifying dengue: a review of the difficulties in using the WHO case classification for dengue haemorrhagic fever. Trop Med Int Health. 2006; 11(8):1238-55. DOI: 10.1111/j.1365-3156.2006.01678.x. View

Kwiecien R, Kopp-Schneider A, Blettner M . Concordance analysis: part 16 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2011; 108(30):515-21. PMC: 3165924. DOI: 10.3238/arztebl.2011.0515. View

Srikiatkhachorn A, Rothman A, Gibbons R, Sittisombut N, Malasit P, Ennis F . Dengue--how best to classify it. Clin Infect Dis. 2011; 53(6):563-7. PMC: 3202316. DOI: 10.1093/cid/cir451. View

10.

Lim S, Lim J, Yoon I . An Update on Zika Virus in Asia. Infect Chemother. 2017; 49(2):91-100. PMC: 5500276. DOI: 10.3947/ic.2017.49.2.91. View

11.

Koraka P, Burghoorn-Maas C, Falconar A, Setiati T, Djamiatun K, Groen J . Detection of immune-complex-dissociated nonstructural-1 antigen in patients with acute dengue virus infections. J Clin Microbiol. 2003; 41(9):4154-9. PMC: 193852. DOI: 10.1128/JCM.41.9.4154-4159.2003. View

12.

Nishanian P, Huskins K, Stehn S, Detels R, Fahey J . A simple method for improved assay demonstrates that HIV p24 antigen is present as immune complexes in most sera from HIV-infected individuals. J Infect Dis. 1990; 162(1):21-8. DOI: 10.1093/infdis/162.1.21. View

13.

Osorio L, Ramirez M, Bonelo A, Villar L, Parra B . Comparison of the diagnostic accuracy of commercial NS1-based diagnostic tests for early dengue infection. Virol J. 2010; 7:361. PMC: 3016282. DOI: 10.1186/1743-422X-7-361. View

14.

Jayathilaka D, Gomes L, Jeewandara C, Jayarathna G, Herath D, Perera P . Role of NS1 antibodies in the pathogenesis of acute secondary dengue infection. Nat Commun. 2018; 9(1):5242. PMC: 6286345. DOI: 10.1038/s41467-018-07667-z. View

15.

Prado P, Almeida Junior J, Abreu L, Silva C, Souza L, Gomes M . Validation and reliability of the rapid diagnostic test 'SD Bioeasy Dengue Duo' for dengue diagnosis in Brazil: a phase III study. Mem Inst Oswaldo Cruz. 2018; 113(8):e170433. PMC: 6014722. DOI: 10.1590/0074-02760170433. View

16.

Shen W, Galula J, Chang G, Wu H, King C, Chao D . Improving dengue viral antigens detection in dengue patient serum specimens using a low pH glycine buffer treatment. J Microbiol Immunol Infect. 2015; 50(2):167-174. DOI: 10.1016/j.jmii.2015.05.008. View

17.

Khampapongpane B, Lewis H, Ketmayoon P, Phonekeo D, Somoulay V, Khamsing A . National dengue surveillance in the Lao People's Democratic Republic, 2006-2012: epidemiological and laboratory findings. Western Pac Surveill Response J. 2014; 5(1):7-13. PMC: 3984965. DOI: 10.5365/WPSAR.2014.5.1.001. View

18.

Simonnet C, Okandze A, Matheus S, Djossou F, Nacher M, Mahamat A . Prospective evaluation of the SD BIOLINE Dengue Duo rapid test during a dengue virus epidemic. Eur J Clin Microbiol Infect Dis. 2017; 36(12):2441-2447. DOI: 10.1007/s10096-017-3083-8. View

19.

Phommasone K, Sengvilaipaseuth O, de Lamballerie X, Vongsouvath M, Phonemixay O, Blacksell S . Temperature and the field stability of a dengue rapid diagnostic test in the tropics. Am J Trop Med Hyg. 2015; 93(1):33-39. PMC: 4497900. DOI: 10.4269/ajtmh.15-0142. View

20.

Phommanivong V, Kanda S, Shimono T, Lamaningao P, Darcy A, Mishima N . Co-circulation of the dengue with chikungunya virus during the 2013 outbreak in the southern part of Lao PDR. Trop Med Health. 2016; 44:24. PMC: 4973078. DOI: 10.1186/s41182-016-0020-y. View