Multi-country evaluation of the sensitivity and specificity of two commercially-available NS1 ELISA assays for dengue diagnosis

PLoS Neglected Tropical Diseases

Volumn 4, Issue 8, 2010, Pages

  Guzman, Maria G ^a   Jaenisch, Thomas ^b   Gaczkowski, Roger ^b   Hang, Vo Thi Ty ^c   Sekaran, Shamala Devi ^d   Kroeger, Axel ^e   Vazquez, Susana ^a   Ruiz, Didye ^a   Martinez, Eric ^a   Mercado, Juan C ^f   Balmaseda, Angel ^f   Harris, Eva ^g   Dimano, Efren ^h   Leano, Prisca Susan A ^h   Yoksan, Sutee ⁱ   Villegas, Elci ^j   Benduzu, Herminia ^j   Villalobos, Iris ^k   Farrar, Jeremy ^c   Simmons, Cameron P ^c  

^a INSTITUTO DE MEDICINA TROPICAL PEDRO KOURÍ   (Cuba)

^b UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^c OXFORD UNIVERSITY CLINICAL RESEARCH UNIT   (Viet Nam)

^d UNIVERSITY OF MALAYA   (Malaysia)

^e WORLD HEALTH ORGANIZATION   (Switzerland)

^f CNDR   (Nicaragua)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h San Lazaro Hospital   (Philippines)

ⁱ MAHIDOL UNIVERSITY   (Thailand)

^j UNIVERSIDAD DE LOS ANDES   (Venezuela)

^k Hospital Central de Maracay   (Venezuela)

more..

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN M; NONSTRUCTURAL PROTEIN 1;

ANTIBODY DETECTION; ARTICLE; ASIA; BLOOD DONOR; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DENGUE; DIAGNOSTIC ACCURACY; DISEASE SEVERITY; EARLY DIAGNOSIS; ENZYME LINKED IMMUNOSORBENT ASSAY; FEVER; HUMAN; IMMUNOASSAY; INTERMETHOD COMPARISON; LABORATORY TEST; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NONHUMAN; SENSITIVITY AND SPECIFICITY; WESTERN HEMISPHERE;

EID: 78149241108     PISSN: 19352727     EISSN: 19352735     Source Type: Journal    
DOI: 10.1371/journal.pntd.0000811     Document Type: Article

References (40)

1. WHO (2008) Dengue and dengue hemorrhagic fever. http://www.who.int/mediacentre/factsheets/fs117/en/ (accessed 05 June 2008) fact sheet No117, revised May 2008.
2. Guzman MG, Kouri G (2002) Dengue: an update. Lancet Infect Dis 2: 33-42.
3. Halstead SB, Suaya JA, Shepard DS (2007) The burden of dengue infection. Lancet 369: 1410-1.
4. Guzman MG, Kouri G (2004) Dengue diagnosis, advances and challenges. Int J Infect Dis 8: 69-80.
5. Vorndam AV, Kuno G (1997) Laboratory Diagnosis of dengue virus infections. CAB International. Kuno DGaG. pp 313-333.
6. Dussart P, Labeau B, Lagathu G, Louis P, Nunes MR, et al. (2006) Evaluation of an enzyme immunoassay for detection of dengue virus NS1 antigen in human serum. Clin Vaccine Immunol.
7. Dussart P, Petit L, Labeau B, Bremand L, Leduc A, et al. (2008) Evaluation of Two New Commercial Tests for the Diagnosis of Acute Dengue Virus Infection Using NS1 Antigen Detection in Human Serum. PLoS Negl Trop Dis 2: e280.
8. Alcon S, Talarmin A, Debruyne M, Falconar A, Deubel V, et al. (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: 376-81.
9. Bessoff K, Delorey M, Sun W, Hunsperger E (2008) Comparison of 2 Commercially Available Dengue NS1 Capture Enzyme-Linked Immunosorbant Assays for Diagnosis of Acute DENV Infection with a Single Clinical Sample. Clin Vaccine Immunol.
10. Kumarasamy V, Wahab AH, Chua SK, Hassan Z, Chem YK, et al. (2007) Evaluation of a commercial dengue NS1 antigen-capture ELISA for laboratory diagnosis of acute dengue virus infection. J Virol Methods 140: 75-9.
11. Chuansumrit A, Chaiyaratana W, Pongthanapisith V, Tangnararatchakit K, Lertwongrath S, et al. (2008) 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 27: 43-8.
12. Hang VT, Nguyet NM, Trung DT, Tricou V, Yoksan S, 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.
13. Young PR, Hilditch PA, Bletchly C, Halloran W (2000) An antigen capture enzyme-linked immunosorbent assay reveals high levels of the dengue virus protein NS1 in the sera of infected patients. J Clin Microbiol 38: 1053-7.
14. Avirutnan P, Punyadee N, Noisakran S, Komoltri C, Thiemmeca S, et al. (2006) Vascular leakage in severe dengue virus infections: a potential role for the nonstructural viral protein NS1 and complement. J Infect Dis 193: 1078-88.
15. Libraty DH, Young PR, Pickering D, Endy TP, Kalayanarooj S, et al. (2002) 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 186: 1165-8.
16. Guzman MG, Rosario D, Kouri G (2006) Diagnosis of dengue virus infection. Molecular Biology of the flavivirus Horizon Bioscience. Borowski P. pp 191-223.
17. Farrar J, Focks D, Gubler D, Barrera R, Guzman MG, et al. (2007) Towards a global dengue research agenda. Trop Med Int Health 12: 695-9.
18. Kroeger A, Nathan M (2006) Dengue: setting the global research agenda. Lancet 368: 2193-2195.
19. Singh KR, Paul SD (1969) Isolation of Dengue viruses in Aedes albopictus cell cultures. Bull World Health Organ 40: 982-3.
20. Lanciotti RS, Calisher CH, Gubler DJ, Chang GJ, Vorndam AV (1992) Rapid detection and typing of dengue viruses from clinical samples by using reverse transcriptase-polymerase chain reaction. J Clin Microbiol 30: 545-51.
21. Laue T, Emmerich P, Schmitz H (1999) Detection of dengue virus RNA in patients after primary or secondary dengue infection by using the TaqMan automated amplification system. J Clin Microbiol 37: 2543-7.
22. Kong YY, Thay CH, Tin TC, Devi S (2006) Rapid detection, serotyping and quantitation of dengue viruses by TaqMan real-time one-step RT-PCR. J Virol Methods.
23. Yong YK, Thayan R, Chong HT, Tan CT, Sekaran SD (2007) Rapid detection and serotyping of dengue virus by multiplex RT-PCR and real-time SYBR green RT-PCR. Singapore Med J 48: 662-8.
24. Vazquez S, Saenz E, Huelva G, Gonzalez A, Kouri G, et al. (1998) Deteccion de IgM contra el virus del dengue en sangre entera absorbida en papel de filtro. [Detection of IgM against the dengue++ virus in whole blood absorbed on filter paper]. Rev Panam Salud Publica 3: 174-8.
25. Lam SK, Devi S, Pang T (1987) Detection of specific IgM in dengue infection. Southeast Asian J Trop Med Public Health 18: 532-8.
26. Vazquez S, Perez AB, Ruiz D, Rodriguez R, Pupo M, et al. (2005) Serological markers during Dengue 3 primary and secondary infections. J Clin Virol 33: 132-137.
27. Innis BL, Nisalak A, Nimmannitya S, Kusalerdchariya S, Chongswasdi V, et al. (1989) An enzyme-linked immunosorbent assay to characterize dengue infections where dengue and Japanese encephalitis co-circulate. Am J Trop Med Hyg 40: 418-27.
28. Burke DS, Nisalak A, Ussery MA (1982) Antibody capture immunoassay detection of japanese encephalitis virus immunoglobulin m and g antibodies in cerebrospinal fluid. J Clin Microbiol 16: 1034-42.
29. Clark DH, Casals J (1958) Techniques for hemagglutination inhibition with arthropodborne viruses. Am J Trop Hyg 7: 561-573.
30. WHO (1997) Dengue Hemorrhagic Fever. Diagnosis, treatment, prevention and control. Geneva. pp 1-84.
31. Buchy F, Yoksan S, Peeling RW, Hunsperger E Laboratory tests for the diagnosis of dengue virus infection.TDR/Scientific Working Group.TDR/ SWG/08 Geneva, Switzerland, 1-5 October. pp 74-85.
32. TDR/WHO (2006) Report on Dengue.TDR/Scientific Working Group.TDR/ SWG/08 Geneva, Switzerland, 1-5 October.
33. Sekaran SD, Ew CL, Subramaniam G, Kanthesh BM (2009) Sensitivity of dengue virus NS-1 detection in primary and secondary infections. African Journal of Microbiology Research 2: 105-110.
34. Sekaran SD, Ew CL, Kanthesh BM, Appanna R, Subramaniam G (2007) Evaluation of dengue NS1 capture ELISA assay for the rapid detection of dengue. J Infect Developing Countries 1: 182-188.
35. Kumarasamy V, Chua SK, Hassan Z, Wahab AH, Chem YK, et al. (2007) Evaluating the sensitivity of a commercial dengue NS1 antigen-capture ELISA for early diagnosis of acute dengue virus infection. Singapore Med J 48: 669-73.
36. Xu H, Di B, Pan YX, Qiu LW, Wang YD, et al. (2006) Serotype 1-specific monoclonal antibody-based antigen capture immunoassay for detection of circulating nonstructural protein NS1: Implications for early diagnosis and serotyping of dengue virus infections. J Clin Microbiol 44: 2872-8.
37. Blacksell SD, Mammen MP, Jr., Thongpaseuth S, Gibbons RV, Jarman RG, et al. (2008) Evaluation of the Panbio dengue virus nonstructural 1 antigen detection and immunoglobulin M antibody enzyme-linked immunosorbent assays for the diagnosis of acute dengue infections in Laos. Diagn Microbiol Infect Dis 60: 43-9.
38. Koraka P, Burghoorn-Maas CP, Falconar A, Setiati TE, Djamiatun K, et al. (2003) Detection of Immune-Complex-Dissociated Nonstructural-1 Antigen in Patients with Acute Dengue Virus Infections. J Clin Microbiol 41: 4154-4159.
39. Hunsperger EA, Yoksan S, Buchy P, Nguyen VC, Sekaran SD, et al. (2009) Evaluation of commercially available anti-dengue virus immunoglobulin M tests. Emerg Infect Dis 15: 436-40.
40. Guzman MG, Pelegrino JL, Pumariega T, Vazquez S, Gonzalez L, et al. (2003) [Quality control of the serological diagnosis of dengue in laboratories throughout the Americas, 1996-2001]. Rev Panam Salud Publica 14: 371-6.