Top

Published in:

Open Access 01-12-2022 | Dengue Virus | Brief Report

Performance of the nonstructural 1 Antigen Rapid Test for detecting all four DENV serotypes in clinical specimens from Bangkok, Thailand

Authors: Kanaporn Poltep, Juthamas Phadungsombat, Nathamon Kosoltanapiwat, Borimas Hanboonkunupakarn, Witthawat Wiriyarat, Sarin Suwanpakdee, Phirom Prompiram, Emi E. Nakayama, Keita Suzuki, Hisahiko Iwamoto, Tatsuo Shioda, Pornsawan Leaungwutiwong

Published in: Virology Journal | Issue 1/2022

Abstract

Background:

Dengue is an arboviral disease that has a large effect on public health in subtropical and tropical countries. Rapid and accurate detection of dengue infection is necessary for diagnosis and disease management. We previously developed highly sensitive immunochromatographic devices, the TKK 1^st and TKK 2^nd kits, based on dengue virus (DENV) nonstructural protein 1 detection. However, these TKK kits were evaluated mainly using DENV type 2 clinical specimens collected in Bangladesh, and further validation using clinical specimens of other serotypes was needed.

Methods:

In the present study, one of the TKK kits, TKK 2^nd, was evaluated using 10 DENV-1, 10 DENV-2, 4 DENV-3, 16 DENV-4, and 10 zika virus-infected clinical specimens collected in Bangkok, Thailand.

Results:

The TKK 2^nd kit successfully detected all four DENV serotypes in patient serum specimens and did not show any cross-reactivities against zika virus serum specimens. The IgM and/or IgG anti-DENV antibodies were detected in seven serum specimens, but did not seem to affect the results of antigen detection in the TKK 2^nd kit.

Conclusion:

The results showed that the TKK 2^nd kit successfully detected all four DENV serotypes in clinical specimens and confirmed the potential of the kit for dengue diagnosis in endemic countries.

Available only for authorised users

World Health Organization (WHO). Global strategy for dengue prevention and control 2012–2020. Geneva: World Health Organization; 2012. ISBN 978 92 4 150 403 4.

Alvarez M, Rodriguez-Roche R, Bernardo L, Vazquez S, Morier L, Gonzalez D, Castro O, Kouri G, Halstead SB, Guzman MG. Dengue hemorrhagic Fever caused by sequential dengue 1–3 virus infections over a long time interval: Havana epidemic, 2001–2002. Am J Trop Med Hyg. 2006;75:1113–7.PubMedCrossRef

Messina JP, Brady OJ, Golding N, Kraemer MUG, Wint GRW, Ray SE, Pigott DM, Shearer FM, Johnson K, Earl L, et al. The current and future global distribution and population at risk of dengue. Nat Microbiol. 2019;4:1508–15.PubMedPubMedCentralCrossRef

Perera R, Kuhn RJ. Structural proteomics of dengue virus. Curr Opin Microbiol. 2008;11:369–77.PubMedPubMedCentralCrossRef

Guzman MG, Halstead SB, Artsob H, Buchy P, Farrar J, Gubler DJ, Hunsperger E, Kroeger A, Margolis HS, Martinez E, et al. Dengue: a continuing global threat. Nat Rev Microbiol. 2010;8:7–16.CrossRef

World Health Organization (WHO). Dengue guidelines for diagnosis, treatment, prevention and control: new edition. Geneva: World Health Organization; 2009. ISBN 978924154787 1.

Alcon-LePoder S, Sivard P, Drouet MT, Talarmin A, Rice C, Flamand M. Secretion of flaviviral non-structural protein NS1: from diagnosis to pathogenesis. In: Novartis Found Symp. 2006;277:233 – 47.

Paranavitane SA, Gomes L, Kamaladasa A, Adikari TN, Wickramasinghe N, Jeewandara C, Shyamali NL, Ogg GS, Malavige GN. Dengue NS1 antigen as a marker of severe clinical disease. BMC Infect Dis. 2014;14:570.PubMedPubMedCentralCrossRef

Peeling RW, Artsob H, Pelegrino JL, Buchy P, Cardosa MJ, Devi S, Enria DA, Farrar J, Gubler DJ, Guzman MG, et al. Evaluation of diagnostic tests: dengue. Nat Rev Microbiol. 2010;8:30-8.

10.

Alcon S, Talarmin A, Debruyne M, Falconar A, Deubel V, Flamand M. Enzyme-linked immunosorbent assay specific to Dengue virus type 1 nonstructural protein NS1 reveals circulation of the antigen in the blood during the acute phase of disease in patients experiencing primary or secondary infections. J Clin Microbiol. 2002;40:376–81.PubMedPubMedCentralCrossRef

11.

Thomas L, Najioullah F, Verlaeten O, Martial J, Brichler S, Kaidomar S, Moravie V, Cabie A, Cesaire R. Relationship between nonstructural protein 1 detection and plasma virus load in Dengue patients. Am J Trop Med Hyg. 2010;83:696–9.PubMedPubMedCentralCrossRef

12.

Sirisena N, Noordeen F, Fernando L. NS1 lasts longer than the dengue virus nucleic acid in the clinically suspected patients with dengue fever and dengue haemorrhagic fever. Virusdisease. 2017;28:341–4.PubMedPubMedCentralCrossRef

13.

Libraty DH, Young PR, Pickering D, Endy TP, Kalayanarooj S, Green S, Vaughn DW, Nisalak A, Ennis FA, Rothman AL. High circulating levels of the dengue virus nonstructural protein NS1 early in dengue illness correlate with the development of dengue hemorrhagic fever. J Infect Dis. 2002;186:1165–8.PubMedCrossRef

14.

Chuansumrit A, Chaiyaratana W, Pongthanapisith V, Tangnararatchakit K, Lertwongrath S, Yoksan S. The use of dengue nonstructural protein 1 antigen for the early diagnosis during the febrile stage in patients with dengue infection. Pediatr Infect Dis J. 2008;27:43–8.PubMedCrossRef

15.

Wilder-Smith A, Renhorn KE, Tissera H, Abu Bakar S, Alphey L, Kittayapong P, Lindsay S, Logan J, Hatz C, Reiter P, et al. DengueTools: innovative tools and strategies for the surveillance and control of dengue. Glob Health Action. 2012;5.

16.

Chaterji S, Allen JC Jr, Chow A, Leo YS, Ooi EE. Evaluation of the NS1 rapid test and the WHO dengue classification schemes for use as bedside diagnosis of acute dengue fever in adults. Am J Trop Med Hyg. 2011;84:224–8.PubMedPubMedCentralCrossRef

17.

Liu LT, Chen CH, Tsai CY, Lin PC, Hsu MC, Huang BY, Wang YH, Tsai JJ. Evaluation of rapid diagnostic tests to detect dengue virus infections in Taiwan. PLoS ONE. 2020;15:e0239710.PubMedPubMedCentralCrossRef

18.

Lee H, Ryu JH, Park HS, Park KH, Bae H, Yun S, Choi AR, Cho SY, Park C, Lee DG, et al. Comparison of Six Commercial Diagnostic Tests for the Detection of Dengue Virus Non-Structural-1 Antigen and IgM/IgG Antibodies. Ann Lab Med. 2019;39:566–71.PubMedPubMedCentralCrossRef

19.

Suzuki K, Nakayama EE, Saito A, Egawa A, Sato T, Phadungsombat J, Rahim R, Hasan A, Iwamoto H, Rahman M, Shioda T. Evaluation of novel rapid detection kits for dengue virus NS1 antigen in Dhaka, Bangladesh, in 2017. Virol J. 2019;16:102.PubMedPubMedCentralCrossRef

20.

Shu PY, Chang SF, Kuo YC, Yueh YY, Chien LJ, Sue CL, Lin TH, Huang JH. Development of group- and serotype-specific one-step SYBR green I-based real-time reverse transcription-PCR assay for dengue virus. J Clin Microbiol. 2003;41:2408–16.PubMedPubMedCentralCrossRef

21.

Lanciotti RS, Kosoy OL, Laven JJ, Velez JO, Lambert AJ, Johnson AJ, Stanfield SM, Duffy MR. Genetic and serologic properties of Zika virus associated with an epidemic, Yap State, Micronesia, 2007. Emerg Infect Dis. 2008;14:1232–9.PubMedPubMedCentralCrossRef

22.

Hunsperger EA, Sharp TM, Lalita P, Tikomaidraubuta K, Cardoso YR, Naivalu T, Khan AS, Marfel M, Hancock WT, Tomashek KM, Margolis HS. Use of a Rapid Test for Diagnosis of Dengue during Suspected Dengue Outbreaks in Resource-Limited Regions. J Clin Microbiol. 2016;54:2090–5.PubMedPubMedCentralCrossRef

23.

Mat Jusoh TNA, Shueb RH. Performance Evaluation of Commercial Dengue Diagnostic Tests for Early Detection of Dengue in Clinical Samples. J Trop Med. 2017;2017:4687182.PubMedPubMedCentralCrossRef

24.

Pal S, Dauner AL, Mitra I, Forshey BM, Garcia P, Morrison AC, Halsey ES, Kochel TJ, Wu SJ. Evaluation of dengue NS1 antigen rapid tests and ELISA kits using clinical samples. PLoS ONE. 2014;9:e113411.PubMedPubMedCentralCrossRef

25.

Teoh BT, Sam SS, Tan KK, Johari J, Abd-Jamil J, Hooi PS, AbuBakar S. The Use of NS1 Rapid Diagnostic Test and qRT-PCR to Complement IgM ELISA for Improved Dengue Diagnosis from Single Specimen. Sci Rep. 2016;6:27663.PubMedPubMedCentralCrossRef

26.

Lim JK, Chanthavanich P, Limkittikul K, Lee JS, Sirivichayakul C, Lee KS, Lim SK, Yoon IK, Hattasingh W. Clinical and epidemiologic characteristics associated with dengue fever in 2011–2016 in Bang Phae district, Ratchaburi province, Thailand. PLoS Negl Trop Dis. 2021;15:e0009513.PubMedPubMedCentralCrossRef

27.

Wongsawat E, Avirutnan P, Kim YW, Suputtamongkol Y. Performance of Two Commercial Dengue NS1 Rapid Tests for the Diagnosis of Adult Patients with Dengue Infection. Siriraj Med J. 2020;72:74–48.CrossRef

28.

Blessmann J, Winkelmann Y, Keoviengkhone L, Sopraseuth V, Kann S, Hansen J, El Halas H, Emmerich P, Schmidt-Chanasit J, Schmitz H, et al. 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). PLoS ONE. 2020;15:e0230337.PubMedPubMedCentralCrossRef

29.

Hang VT, Nguyet NM, Trung DT, Tricou V, Yoksan S, Dung NM, Van Ngoc T, Hien TT, Farrar J, Wills B, Simmons CP. Diagnostic accuracy of NS1 ELISA and lateral flow rapid tests for dengue sensitivity, specificity and relationship to viraemia and antibody responses. PLoS Negl Trop Dis. 2009;3:e360.PubMedCrossRef

30.

Muller DA, Depelsenaire AC, Young PR. Clinical and Laboratory Diagnosis of Dengue Virus Infection. J Infect Dis. 2017;215:89–95.CrossRef

31.

Tricou V, Minh NN, Farrar J, Tran HT, Simmons CP. Kinetics of viremia and NS1 antigenemia are shaped by immune status and virus serotype in adults with dengue. PLoS Negl Trop Dis. 2011;5:e1309.PubMedPubMedCentralCrossRef

32.

Labrique AB, Pan WK. Diagnostic tests: understanding results, assessing utility, and predicting performance. Am J Ophthalmol. 2010;149:878–81 e872.PubMedPubMedCentralCrossRef

33.

Yu L, Wen Y, Xiang M, Hong W, Zhao L, Zhang F. The Limitation of Rapid Tests for DENV2 Infection in Host with Unique Immune Status: Low NS1 Antigenemia and Deficient Antibody Responses. Virol Sin. 2020;35:478–80.PubMedPubMedCentralCrossRef

34.

Watanabe S, Tan KH, Rathore AP, Rozen-Gagnon K, Shuai W, Ruedl C, Vasudevan SG. The magnitude of dengue virus NS1 protein secretion is strain dependent and does not correlate with severe pathologies in the mouse infection model. J Virol. 2012;86:5508–14.PubMedPubMedCentralCrossRef

35.

Felix AC, Romano CM, Centrone Cde C, Rodrigues CL, Villas-Boas L, Araujo ES, de Matos AM, Carvalho KI, Martelli CM, Kallas EG, et al. Low sensitivity of NS1 protein tests evidenced during a dengue type 2 virus outbreak in Santos, Brazil, in 2010. Clin Vaccine Immunol. 2012;19:1972–6.PubMedPubMedCentralCrossRef

36.

Ngim CF, Husain SMT, Hassan SS, Dhanoa A, Ahmad SAA, Mariapun J, Wan Ismail WF, Botross Henien NP, Jahan NK, Pong LY, et al. Rapid testing requires clinical evaluation for accurate diagnosis of dengue disease: A passive surveillance study in Southern Malaysia. PLoS Negl Trop Dis. 2021;15:e0009445.PubMedPubMedCentralCrossRef

37.

Wongsawat E, Suputtamongkol Y, Assanasaen S, Silpasakorn S, Avirutnan P, Puttikhunt C, Angkasekwinai N, Yamasmith E, Prommool T, Niwattayakul K. Performance of a New Microfluidic Dengue NS1 Immuno-magnetic Agglutination Assay for the Rapid Diagnosis of Dengue Infection in Adults. Am J Trop Med Hyg. 2021;105:771–6.PubMedPubMedCentralCrossRef

38.

Prommool T, Sethanant P, Phaenthaisong N, Tangthawornchaikul N, Songjaeng A, Avirutnan P, Mairiang D, Luangaram P, Srisawat C, Kasinrerk W, et al. High performance dengue virus antigen-based serotyping-NS1-ELISA (plus): A simple alternative approach to identify dengue virus serotypes in acute dengue specimens. PLoS Negl Trop Dis. 2021;15:e0009065.PubMedPubMedCentralCrossRef

39.

Bessoff K, Delorey M, Sun W, Hunsperger E. Comparison of two commercially available dengue virus (DENV) NS1 capture enzyme-linked immunosorbent assays using a single clinical sample for diagnosis of acute DENV infection. Clin Vaccine Immunol. 2008;15:1513–8.PubMedPubMedCentralCrossRef

40.

Alejo-Cancho I, Navero-Castillejos J, Peiro-Mestres A, Albarracin R, Barrachina J, Navarro A, Gonzalo V, Pastor V, Munoz J, Martinez MJ. Evaluation of a novel microfluidic immuno-magnetic agglutination assay method for detection of dengue virus NS1 antigen. PLoS Negl Trop Dis. 2020;14:e0008082.PubMedPubMedCentralCrossRef

41.

Poltep K, Nakayama EE, Sasaki T, Kurosu T, Takashima Y, Phadungsombat J, Kosoltanapiwat N, Hanboonkunupakarn B, Suwanpakdee S, Imad HA, et al: Development of a Dengue Virus Serotype-Specific Non-Structural Protein 1 Capture Immunochromatography Method. Sensors (Basel) 2021, 21.

42.

Duyen HT, Ngoc TV, Ha do T, Hang VT, Kieu NT, Young PR, Farrar JJ, Simmons CP, Wolbers M, Wills BA. Kinetics of plasma viremia and soluble nonstructural protein 1 concentrations in dengue: differential effects according to serotype and immune status. J Infect Dis. 2011;203:1292–300.PubMedPubMedCentralCrossRef

43.

Shan X, Wang X, Yuan Q, Zheng Y, Zhang H, Wu Y, Yang J. Evaluation of the diagnostic accuracy of nonstructural protein 1 Ag-based tests for dengue virus in Asian population: a meta-analysis. BMC Infect Dis. 2015;15:360.PubMedPubMedCentralCrossRef

44.

Allonso D, Meneses MD, Fernandes CA, Ferreira DF, Mohana-Borges R. Assessing positivity and circulating levels of NS1 in samples from a 2012 dengue outbreak in Rio de Janeiro, Brazil. PLoS ONE. 2014;9:e113634.PubMedPubMedCentralCrossRef

45.

Acosta PO, Granja F, Meneses CA, Nascimento IA, Sousa DD, Lima Junior WP, Naveca FG. False-negative dengue cases in Roraima, Brazil: an approach regarding the high number of negative results by NS1 ag kits. Rev Inst Med Trop Sao Paulo. 2014;56:447–50.PubMedPubMedCentralCrossRef

46.

Colombo TE, Vedovello D, Araki CS, Cogo-Moreira H, dos Santos IN, Reis AF, Costa FR, Cruz LE, Casagrande L, Regatieri LJ, et al. Dengue-4 false negative results by Panbio(R) Dengue Early ELISA assay in Brazil. J Clin Virol. 2013;58:710–2.PubMedCrossRef

47.

Sea VR, Cruz AC, Gurgel RQ, Nunes BT, Silva EV, Dolabella SS, dos Santos RL. Underreporting of Dengue-4 in Brazil due to low sensitivity of the NS1 Ag test in routine control programs. PLoS ONE. 2013;8:e64056.PubMedPubMedCentralCrossRef

48.

Hermann LL, Thaisomboonsuk B, Poolpanichupatam Y, Jarman RG, Kalayanarooj S, Nisalak A, Yoon IK, Fernandez S. Evaluation of a dengue NS1 antigen detection assay sensitivity and specificity for the diagnosis of acute dengue virus infection. PLoS Negl Trop Dis. 2014;8:e3193.PubMedPubMedCentralCrossRef

49.

Fry SR, Meyer M, Semple MG, Simmons CP, Sekaran SD, Huang JX, McElnea C, Huang CY, Valks A, Young PR, Cooper MA. The diagnostic sensitivity of dengue rapid test assays is significantly enhanced by using a combined antigen and antibody testing approach. PLoS Negl Trop Dis. 2011;5:e1199.PubMedPubMedCentralCrossRef

50.

Yow KS, Aik J, Tan EY, Ng LC, Lai YL. Rapid diagnostic tests for the detection of recent dengue infections: An evaluation of six kits on clinical specimens. PLoS ONE. 2021;16:e0249602.PubMedPubMedCentralCrossRef

51.

Nunes PCG, Nogueira RMR, Heringer M, Chouin-Carneiro T, Damasceno Dos Santos Rodrigues C, de Filippis AMB, Lima M, Dos Santos FB: NS1 Antigenemia and Viraemia Load: Potential Markers of Progression to Dengue Fatal Outcome? Viruses 2018, 10.

52.

Lustig Y, Keler S, Kolodny R, Ben-Tal N, Atias-Varon D, Shlush E, Gerlic M, Munitz A, Doolman R, Asraf K, et al. Potential Antigenic Cross-reactivity Between Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Dengue Viruses. Clin Infect Dis. 2021;73:e2444–9.PubMedCrossRef

53.

Yan G, Lee CK, Lam LTM, Yan B, Chua YX, Lim AYN, Phang KF, Kew GS, Teng H, Ngai CH, et al. Covert COVID-19 and false-positive dengue serology in Singapore. Lancet Infect Dis. 2020;20:536.PubMedPubMedCentralCrossRef

Title: Performance of the nonstructural 1 Antigen Rapid Test for detecting all four DENV serotypes in clinical specimens from Bangkok, Thailand
Authors: Kanaporn Poltep
Juthamas Phadungsombat
Nathamon Kosoltanapiwat
Borimas Hanboonkunupakarn
Witthawat Wiriyarat
Sarin Suwanpakdee
Phirom Prompiram
Emi E. Nakayama
Keita Suzuki
Hisahiko Iwamoto
Tatsuo Shioda
Pornsawan Leaungwutiwong
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Dengue Virus
Zika Virus
Published in: Virology Journal / Issue 1/2022
Electronic ISSN: 1743-422X
DOI: https://doi.org/10.1186/s12985-022-01904-0

ACC 2024 Congress Coverage

Heart Failure Video

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Performance of the nonstructural 1 Antigen Rapid Test for detecting all four DENV serotypes in clinical specimens from Bangkok, Thailand

Abstract

Background:

Methods:

Results:

Conclusion:

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background:

Methods:

Results:

Conclusion:

Please log in to get access to this content

Other articles of this Issue 1/2022

Assessment of antibody responses against SARS-CoV-2 in unvaccinated individuals and vaccinees from Omicron-BA.2 infection in Zhaoqing, Guangdong Province, China

Comprehensive virome analysis of the viral spectrum in paediatric patients diagnosed with Mycoplasma pneumoniae pneumonia

Correction to: Human papillomavirus genotype distribution in Ethiopia: an updated systematic review

Development of a multiplex RT-PCR assay for simultaneous detection of Lily symptomless virus, Lily mottle virus, Cucumber mosaic virus, and Plantago asiatica mosaic virus in Lilies

Death from human cytomegalovirus infection in a girl with congenital thymic dysplasia

SARS-CoV-2 infection in pediatric population before and during the Delta (B.1.617.2) and Omicron (B.1.1.529) variants era

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page