title: Comparison of two rapid diagnostic assays for detection of immunoglobulin M antibodies to dengue virus.
abstract: Two easy-to-use commercial diagnostic assays, a dipstick enzyme-linked immunosorbent assay (ELISA) (Integrated Diagnostics, Baltimore, Md.) and an immunochromatographic card assay (PanBio, Brisbane, Australia) were evaluated for detection of immunoglobulin M (IgM) antibody to dengue virus with an in-house IgM antibody capture microplate ELISA as a reference assay. The dipstick ELISA was based on the indirect-ELISA format using dengue 2 virus as the only antigen and enzyme-labeled goat anti-human IgM antibody as the detector. The total assay time was 75 min. The immunochromatographic card assay was based on the antibody capture format and separately measured both anti-dengue virus IgM and IgG in the same test. Colloidal-gold-labeled anti-dengue virus monoclonal antibody bound with dengue virus 1 to 4 antigen cocktail was the detector, and anti-human IgM and IgG were the capture antibodies. The total assay time was <10 min. Sera from 164 individuals classified as either anti-dengue virus IgM positive (94) or anti-dengue virus IgM negative (70) in the reference microplate ELISA with a dengue virus 1 to 4 antigen cocktail were tested in the two commercial assays. The dipstick ELISA missed 7 of 94 positive samples, for a sensitivity of 92.6%, while the immunochromatographic card assay missed two positive samples, for a sensitivity of 97.9%. Of the 70 negative samples, four were false positive by the dipstick ELISA and two were false positive in the immunochromatographic card assay, resulting in specificities of 94.3 and 97.1%, respectively. Both commercial assays provide sensitive and specific detection of anti-dengue virus IgM antibody and could prove useful in settings where the microplate ELISA is impractical.
authors.affiliation: Viral and Rickettsial Diseases Department, Naval Medical Research Center, Bethesda, Maryland 20889-5607, USA. WuS@nmripo.nnmc.navy.mil
authors.forename: S J
authors.initials: SJ
authors.lastname: Wu
authors.forename: H
authors.initials: H
authors.lastname: Paxton
authors.forename: B
authors.initials: B
authors.lastname: Hanson
authors.forename: C G
authors.initials: CG
authors.lastname: Kung
authors.forename: T B
authors.initials: TB
authors.lastname: Chen
authors.forename: C
authors.initials: C
authors.lastname: Rossi
authors.forename: D W
authors.initials: DW
authors.lastname: Vaughn
authors.forename: G S
authors.initials: GS
authors.lastname: Murphy
authors.forename: C G
authors.initials: CG
authors.lastname: Hayes
mesh_terms: D000911:Antibodies, Monoclonal / Q000276:immunology*; D003716:Dengue Virus / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D017979:Gold Colloid / Q000737:chemistry; D006801:Humans; D007120:Immunochemistry / Q000379:methods; D007074:Immunoglobulin G / Q000276:immunology*; D007075:Immunoglobulin M / Q000302:isolation & purification*; D007159:Immunologic Tests / Q000379:methods*; D066298:In Vitro Techniques; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D017979:Gold Colloid; D007074:Immunoglobulin G; D007075:Immunoglobulin M