title: Evaluation of ASSURE® Dengue IgA Rapid Test using dengue-positive and dengue-negative samples.
abstract: ASSURE® Dengue IgA Rapid Test, an immunochromatographic anti-Dengue IgA Rapid Test based on reverse flow technology, was evaluated using archived sera. The sera were obtained during hospital admission and discharge of 204 patients during 2000 to 2001 dengue outbreak in Bangladesh and 220 negative sera collected in 2009. Based on characterization by reference ELISA (nonstructural protein 1 [NS1] Ag ELISA, immunoglobulin M [IgM]-Cap ELISA, and immunoglobulin G [IgG]-Cap ELISA), 179 (87.7%) patients were positive for dengue infection, and the remaining 245 patients had nondengue febrile illness. The performance of Dengue IgA Rapid Test was compared to reference ELISA. Of 179 dengue-positive sera, 79 (44.1%) were positive by NS1 Ag ELISA, 174 (97.2%) were positive by IgM-Cap ELISA, and 142 (79.3%) were positive by IgG-Cap ELISA. Among 142 IgG-positive cases, 121 (85.2%) patients had shown high level of IgG (PanBio units ≥ 22, equivalent to hemagglutination inhibition (HI) titer ≥ 2560) during hospital admission, indicating secondary infections. Dengue IgA Rapid Test demonstrated 99.4% (178 of 179) sensitivity in diagnosing dengue infection with the ability to detect 100% primary (58 of 58) and 99.2% (120 of 121) secondary infections, and the specificity was found 99.2% (2 of 245). The capability of Dengue IgA Rapid Test in detecting dengue infection in terms of day of illness was comparable to reverse transcriptase polymerase chain reaction and was found better than in-house IgM ELISA. Compared with in-house IgM ELISA, Dengue IgA Rapid Test also detected similar number of dengue virus (DENV) 1, DENV 2, and more DENV 3 and DENV 4 cases. The overall performance thus suggested its usefulness as one of the dengue early diagnostic tools where diagnostic facility is limited.
authors.affiliation: International Centre for Diarrhoeal Disease Research, Dhaka 1212, Bangladesh.
authors.forename: Firoz
authors.initials: F
authors.lastname: Ahmed
authors.forename: Huzzatul
authors.initials: H
authors.lastname: Mursalin
authors.forename: Meer Taifur
authors.initials: MT
authors.lastname: Alam
authors.forename: Ruhul
authors.initials: R
authors.lastname: Amin
authors.forename: Shamala Devi
authors.initials: SD
authors.lastname: Sekaran
authors.forename: Seok Mui
authors.initials: SM
authors.lastname: Wang
authors.forename: Yun Ying
authors.initials: YY
authors.lastname: Tan
authors.forename: Bijon Kumar
authors.initials: BK
authors.lastname: Sil
authors.forename: M Anowar
authors.initials: MA
authors.lastname: Hossain
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D000956:Antigens, Viral / Q000276:immunology; D001459:Bangladesh; D002845:Chromatography / Q000379:methods; D003715:Dengue / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D003716:Dengue Virus / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013997:Time Factors; D017361:Viral Nonstructural Proteins / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D000956:Antigens, Viral; D007070:Immunoglobulin A; C082515:NS1 protein, dengue-1 virus; D011933:Reagent Kits, Diagnostic; D017361:Viral Nonstructural Proteins