ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Shepard DS , Undurraga EA , Halasa YA , Stanaway JD , 2016. The global economic burden of dengue: a systematic analysis. Lancet Infect Dis 16: 935–941. doi: 10.1016/S1473-3099(16)00146-8.
-
2.
World Health Organization , 2012. Global strategy for dengue prevention and control, 2012–2020. Available at: https://www.who.int/ denguecontrol/9789241504034/en/. Accessed October 2019.
-
3.
Alcon S , Talarmin A , Debruyne M , Falconar A , Deubel V , Flamand M , 2002. 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 40: 376–381.
-
4.
Guzman MG et al., 2010. Dengue: a continuing global threat. Nat Rev Microbiol 8 (Suppl ):S7–S16. doi: 10.1038/nrmicro2460.
-
5.
Hu D , Di B , Ding X , Wang Y , Chen Y , Pan Y , Wen K , Wang M , 2011. Kinetics of non-structural protein 1, IgM and IgG antibodies in dengue type 1 primary infection. Virol J 47. doi: 10.1186/1743-422X-8-47.
-
6.
Casenghi M , Kosack C , Li R , Bastard M , Ford N , 2018. NS1 antigen detecting assays for diagnosing acute dengue infection in people living in or returning from endemic countries. Cochrane Database Syst Rev 5: 2–5. doi: 10.1002/14651858.CD011155.pub2.
-
7.
Hang VT et al., 2009. 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 3: e360. doi: 10.1371/journal.pntd.0000360.
-
8.
Pal S , Dauner AL , Mitra I , Forshey BM , Garcia P , Morrison AC , Halsey ES , Kochel TJ , Wu S-JL , 2014. Evaluation of dengue NS1 antigen rapid tests and ELISA kits using clinical samples. PLoS One 9: e113411. doi: 10.1371/journal.pone.0113411.
-
9.
Raafat N , Blacksell SD , Maude RJ , 2019. A review of dengue diagnostics and implications for surveillance and control. Trans R Soc Trop Med Hyg 113: 653–660. doi: 10.1093/trstmh/trz068.
-
10.
Chong ZL , Sekaran SD , Soe HJ , Peramalah D , Rampal S , Ng C-W , 2020. Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia. BMC Infect Dis 20: 210. doi: 10.1186/s12879-020-4911-5.
-
11.
Alejo-Cancho I , Navero-Castillejos J , Peiró-Mestres A , AlbarracÃn R , Barrachina J , Navarro A , Gonzalo V , Pastor V , Muñoz J & Miguel JM, 2020. Evaluation of a novel microfluidic immuno-magnetic agglutination assay method for detection of dengue virus NS1 antigen. PLoS Negl Trop Dis 14: e0008082. doi: 10.1371/journal.pntd.0008082.
-
12.
Suputtamongkol Y et al., 2021. Ivermectin accelerates circulating nonstructural protein 1 (NS1) clearance in adult dengue patients: a combined phase 2/3 randomized double-blinded placebo controlled trial. Clin Infect Dis 72: e586–e593. doi: 10.1093/cid/ciaa1332.
-
13.
Shu PY, Chang SF, Kuo YC, Yueh YY, Chien LJ, Sue CL, Lin TH, Huang JH, 2003. Development of group- and serotype-specific one-step SYBR green 1-based real-time reverse transcription-PeR assay for dengue virus. J Clin Microbiol 41: 2408--2416.
-
14.
Puttikhunt C et al., 2011 . The development of a novel serotyping-NS1-ELISA to identify serotypes of dengue virus. J Clin Virol 50: 314–319. doi: 10.1016/j.jcv.2011.01.001.
-
15.
Innis BL , Nisalak A , Nimmannitya S , Kusalerdchariya S , Chongswasdi V , Suntayakorn S , Puttisri P , Hoke CH , 1989. An enzyme-linked immunosorbent assay to characterize dengue infections where dengue and Japanese encephalitis co-circulate. Am J Trop Med Hyg 40: 418–427.
-
16.
Suttinont C et al., 2006. Causes of acute undifferentiated febrile illness in rural Thailand: a prospective observational study. Ann Trop Med Hyg 100: 363–370.
-
17.
Thipmontree W , Suputtamongkol Y , Tantibhedhyangkul W , Suttinont C , Wongsawat E , Silpasakorn S , 2014. Human leptospirosis trends: northeast Thailand, 2001–2012. Int J Environ Res Public Health 11: 8542–8551. doi: 10.3390/ijerph110808542.
-
18.
Clopper CJ , Pearson ES , 1934. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26: 404–413.
-
19.
Trajman A , Lui ZRR , 2008. McNemar χ2 test revisited: comparing sensitivity and specificity of diagnostic examinations. Scand J Clin Lab Invest 68: 77–80.
-
20.
Roy P , Gaur R , Anand A , 2019. Evaluation of a novel immuno-magnetic assay technology for rapid detection of dengue NS1 antigen. Inter J Res Med Sci. 8: 129. doi: 10.18203/2320-6012.ijrms20195895.
-
21.
Matheus S , Boukhari R , Labeau B , Ernault V , Bremand L , Kazanji M , Rousset D , 2016. Specificity of dengue NS1 antigen in differential diagnosis of dengue and Zika virus infection. Emerg Infect Dis 22: 1691–1693. doi: 10.3201/eid2209.160725.
-
22.
Lee H et al., 2019. Comparison of six commercial diagnostic tests for the detection of dengue virus non-structural-1 antigen and IgM/IgG antibodies. Ann Lab Med 39: 566–571. doi: 10.3343/alm.2019.39.6.566.
-
23.
Bessoff K , Delorey M , Sun W , Hunsperger E , 2008. 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 15: 1513–1518. doi: 10.1128/CVI.00140-08.
-
24.
Ramirez AH , Moros Z , Comach G , Zambrano J , Bravo L , Pinto B , Vielma S , Cardier J , Liprandi F , 2009. Evaluation of dengue NS1 antigen detection tests with acute sera from patients infected with dengue virus in Venezuela. Diagn Microbiol Infect Dis 65: 247–253. doi: 10.1016/j.diagmicrobio.2009.07.022.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 2173 | 897 | 253 |
| Full Text Views | 273 | 20 | 1 |
| PDF Downloads | 368 | 21 | 1 |
Performance of a New Microfluidic Dengue NS1 Immuno-magnetic Agglutination Assay for the Rapid Diagnosis of Dengue Infection in Adults
Ekkarat Wongsawat
Ekkarat Wongsawat
Division of Infectious Diseases and Tropical Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
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Yupin Suputtamongkol
Yupin Suputtamongkol
Division of Infectious Diseases and Tropical Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
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Susan Assanasaen
Susan Assanasaen
Division of Infectious Diseases and Tropical Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
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Saowaluk Silpasakorn
Saowaluk Silpasakorn
Division of Infectious Diseases and Tropical Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
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Panisadee Avirutnan
Panisadee Avirutnan
Division of Dengue Hemorrhagic Fever Research, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
Siriraj Center of Research Excellence in Dengue & Emerging Pathogens, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
Molecular Biology of Dengue and Flaviviruses Research Team, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency, Klong Luang, Pathumthani, Thailand;
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Siriraj Center of Research Excellence in Dengue & Emerging Pathogens, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
Molecular Biology of Dengue and Flaviviruses Research Team, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency, Klong Luang, Pathumthani, Thailand;
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Chunya Puttikhunt
Chunya Puttikhunt
Division of Dengue Hemorrhagic Fever Research, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
Siriraj Center of Research Excellence in Dengue & Emerging Pathogens, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
Molecular Biology of Dengue and Flaviviruses Research Team, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency, Klong Luang, Pathumthani, Thailand;
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Siriraj Center of Research Excellence in Dengue & Emerging Pathogens, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
Molecular Biology of Dengue and Flaviviruses Research Team, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency, Klong Luang, Pathumthani, Thailand;
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Nasikarn Angkasekwinai
Nasikarn Angkasekwinai
Division of Infectious Diseases and Tropical Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
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Eakkawit Yamasmith
Eakkawit Yamasmith
Division of Infectious Diseases and Tropical Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;
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Tanapan Prommool
Tanapan Prommool
Molecular Biology of Dengue and Flaviviruses Research Team, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency, Klong Luang, Pathumthani, Thailand;
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Kanigar Niwattayakul
Kanigar Niwattayakul
Medical Department, Loei Provincial Hospital, Ministry of Health, Loei, Thailand
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ABSTRACT.
Dengue (DENV) infections are a public health concern worldwide and thus early diagnosis is important to ensure appropriate clinical management. The rapid diagnostic test (RDT) targets nonstructural protein 1 (NS1) detection and is the main tool used for diagnostic purpose. In this study, we evaluated the performance of a new rapid and semi-quantitative microfluidic DENV NS1 immuno-magnetic agglutination assay or IMA (ViroTrack Dengue Acute, BluSense Diagnostics, Copenhagen, Denmark). We studied 233 subjects confirmed to have DENV infection (by a real-time reverse transcriptase polymerase chain reaction) and 200 control samples were taken from patients with confirmed diagnoses of other febrile illnesses, in Thailand. Samples were tested using the NS1 antigen (Ag) detection methods: in-house NS1 Ag ELISA (ELISA), SD BIOLINE Dengue NS1 Ag RDT (ICT), and ViroTrack Dengue Acute (IMA). Sensitivities of these tests were 86.3%, 78.9%, and 85.5%, respectively. All tests showed high specificity (100%, 99%, and 97% for ELISA, ICT, and IMA, respectively). The sensitivities of both RDTs were affected by the low sensitivity to DENV-2 and DENV-4. NS1 Ag was detected in every patient on day 1 and day 2 after onset of illness by ELISA and IMA with a decline in detection rates over time after day 6 of illness. NS1 detection rate using ICT decreased from 100% on day 1 of illness to 98.6% on day 2 after onset of illness. By day 6, the detection rate was 45.9%. Thus, IMA performed better than ICT for early and rapid diagnosis of DENV infections in endemic countries.
Author Notes
Disclosure: The Ethical Committee at the Faculty Medicine Siriraj Hospital, Mahidol University, approved the study protocol (COA no: Si200/2019).
Authors’ addresses: Ekkarat Wongsawat, Yupin Suputtamongkol, Susan Assanasaen, Saowaluk Silpasakorn, Nasikarn Angkasekwinai, and Eakkawit Yamasmith, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand, E-mails: ewongsawat@gmail.com, ysuputtamongkol@gmail.com, susan.ass@mahidol.ac.th, saowaluksilpasakorn@gmail.com, nasikarn@gmail.com, and mike_th99@hotmail.com. Panisadee Avirutnan, Siriraj Center of Research Excellence in Dengue & Emerging Pathogens, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand, E-mail: panisadee.avi@mahidol.edu. Chunya Puttikhunt, Molecular Biology of Dengue and Flaviviruses Research Team, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency, Klong Luang, Pathumthani, Thailand, E-mail: chaunyapk@biotec.or.th.Tanapan Prommool, Molecular Biology of Dengue and Flaviviruses Research Team, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency, Klong Luang, Pathumthani, Thailand, E-mail: tanapan.pro@biotec.or.th. Kanigar Niwattayakul, Loei Hospital, Loei Province, Thailand, E-mail: janthira1817@gmail.com.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Shepard DS , Undurraga EA , Halasa YA , Stanaway JD , 2016. The global economic burden of dengue: a systematic analysis. Lancet Infect Dis 16: 935–941. doi: 10.1016/S1473-3099(16)00146-8.
-
2.
World Health Organization , 2012. Global strategy for dengue prevention and control, 2012–2020. Available at: https://www.who.int/ denguecontrol/9789241504034/en/. Accessed October 2019.
-
3.
Alcon S , Talarmin A , Debruyne M , Falconar A , Deubel V , Flamand M , 2002. 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 40: 376–381.
-
4.
Guzman MG et al., 2010. Dengue: a continuing global threat. Nat Rev Microbiol 8 (Suppl ):S7–S16. doi: 10.1038/nrmicro2460.
-
5.
Hu D , Di B , Ding X , Wang Y , Chen Y , Pan Y , Wen K , Wang M , 2011. Kinetics of non-structural protein 1, IgM and IgG antibodies in dengue type 1 primary infection. Virol J 47. doi: 10.1186/1743-422X-8-47.
-
6.
Casenghi M , Kosack C , Li R , Bastard M , Ford N , 2018. NS1 antigen detecting assays for diagnosing acute dengue infection in people living in or returning from endemic countries. Cochrane Database Syst Rev 5: 2–5. doi: 10.1002/14651858.CD011155.pub2.
-
7.
Hang VT et al., 2009. 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 3: e360. doi: 10.1371/journal.pntd.0000360.
-
8.
Pal S , Dauner AL , Mitra I , Forshey BM , Garcia P , Morrison AC , Halsey ES , Kochel TJ , Wu S-JL , 2014. Evaluation of dengue NS1 antigen rapid tests and ELISA kits using clinical samples. PLoS One 9: e113411. doi: 10.1371/journal.pone.0113411.
-
9.
Raafat N , Blacksell SD , Maude RJ , 2019. A review of dengue diagnostics and implications for surveillance and control. Trans R Soc Trop Med Hyg 113: 653–660. doi: 10.1093/trstmh/trz068.
-
10.
Chong ZL , Sekaran SD , Soe HJ , Peramalah D , Rampal S , Ng C-W , 2020. Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia. BMC Infect Dis 20: 210. doi: 10.1186/s12879-020-4911-5.
-
11.
Alejo-Cancho I , Navero-Castillejos J , Peiró-Mestres A , AlbarracÃn R , Barrachina J , Navarro A , Gonzalo V , Pastor V , Muñoz J & Miguel JM, 2020. Evaluation of a novel microfluidic immuno-magnetic agglutination assay method for detection of dengue virus NS1 antigen. PLoS Negl Trop Dis 14: e0008082. doi: 10.1371/journal.pntd.0008082.
-
12.
Suputtamongkol Y et al., 2021. Ivermectin accelerates circulating nonstructural protein 1 (NS1) clearance in adult dengue patients: a combined phase 2/3 randomized double-blinded placebo controlled trial. Clin Infect Dis 72: e586–e593. doi: 10.1093/cid/ciaa1332.
-
13.
Shu PY, Chang SF, Kuo YC, Yueh YY, Chien LJ, Sue CL, Lin TH, Huang JH, 2003. Development of group- and serotype-specific one-step SYBR green 1-based real-time reverse transcription-PeR assay for dengue virus. J Clin Microbiol 41: 2408--2416.
-
14.
Puttikhunt C et al., 2011 . The development of a novel serotyping-NS1-ELISA to identify serotypes of dengue virus. J Clin Virol 50: 314–319. doi: 10.1016/j.jcv.2011.01.001.
-
15.
Innis BL , Nisalak A , Nimmannitya S , Kusalerdchariya S , Chongswasdi V , Suntayakorn S , Puttisri P , Hoke CH , 1989. An enzyme-linked immunosorbent assay to characterize dengue infections where dengue and Japanese encephalitis co-circulate. Am J Trop Med Hyg 40: 418–427.
-
16.
Suttinont C et al., 2006. Causes of acute undifferentiated febrile illness in rural Thailand: a prospective observational study. Ann Trop Med Hyg 100: 363–370.
-
17.
Thipmontree W , Suputtamongkol Y , Tantibhedhyangkul W , Suttinont C , Wongsawat E , Silpasakorn S , 2014. Human leptospirosis trends: northeast Thailand, 2001–2012. Int J Environ Res Public Health 11: 8542–8551. doi: 10.3390/ijerph110808542.
-
18.
Clopper CJ , Pearson ES , 1934. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26: 404–413.
-
19.
Trajman A , Lui ZRR , 2008. McNemar χ2 test revisited: comparing sensitivity and specificity of diagnostic examinations. Scand J Clin Lab Invest 68: 77–80.
-
20.
Roy P , Gaur R , Anand A , 2019. Evaluation of a novel immuno-magnetic assay technology for rapid detection of dengue NS1 antigen. Inter J Res Med Sci. 8: 129. doi: 10.18203/2320-6012.ijrms20195895.
-
21.
Matheus S , Boukhari R , Labeau B , Ernault V , Bremand L , Kazanji M , Rousset D , 2016. Specificity of dengue NS1 antigen in differential diagnosis of dengue and Zika virus infection. Emerg Infect Dis 22: 1691–1693. doi: 10.3201/eid2209.160725.
-
22.
Lee H et al., 2019. Comparison of six commercial diagnostic tests for the detection of dengue virus non-structural-1 antigen and IgM/IgG antibodies. Ann Lab Med 39: 566–571. doi: 10.3343/alm.2019.39.6.566.
-
23.
Bessoff K , Delorey M , Sun W , Hunsperger E , 2008. 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 15: 1513–1518. doi: 10.1128/CVI.00140-08.
-
24.
Ramirez AH , Moros Z , Comach G , Zambrano J , Bravo L , Pinto B , Vielma S , Cardier J , Liprandi F , 2009. Evaluation of dengue NS1 antigen detection tests with acute sera from patients infected with dengue virus in Venezuela. Diagn Microbiol Infect Dis 65: 247–253. doi: 10.1016/j.diagmicrobio.2009.07.022.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 2173 | 897 | 253 |
| Full Text Views | 273 | 20 | 1 |
| PDF Downloads | 368 | 21 | 1 |