title: 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.
abstract: Dengue virus (DENV) nonstructural protein 1 (NS1) has shown promise as a novel diagnostic marker of acute DENV infection. Current techniques used to diagnose acute DENV infection, including virus isolation and reverse transcription-PCR (RT-PCR), are costly and difficult to perform, while traditional serological assays have low sensitivities during the acute stage of infection. Two commercially available NS1 antigen capture enzyme-linked immunosorbent assays (ELISAs), the Platelia dengue NS1Ag test (Bio-Rad Laboratories, Marnes La Coquette, France) and the Pan-E dengue early ELISA test (Panbio Diagnostics, Brisbane, Australia), were evaluated against a well-characterized panel of 208 real-time RT-PCR- and virus isolation-positive sera, as well as 45 real-time RT-PCR- and serologically negative sera from patients with other acute febrile illnesses. The overall sensitivities were 64.9% (95% confidence interval [CI(95)], 58.2 to 71.1%) for the Panbio test and 83.2% (CI(95), 77.5 to 87.7%) for the Bio-Rad test, with interserotype variation, especially for DENV serotype 4. Predictive models were constructed to identify factors that had a significant influence on a test's outcome with respect to this panel of samples in order to identify the conditions in which the test will be most effective as a diagnostic tool. The immunoglobulin G titer was found to be the only covariate that significantly influenced results in the Bio-Rad test, while serotype and the day postonset were found to significantly influence results in the Panbio test. We concluded that the NS1 capture ELISA is a useful tool that can improve testing algorithms to diagnose DENV infection in single samples from acute and early convalescent cases.
authors.affiliation: Centers for Disease Control and Prevention, Division of Vector-Borne Infectious Diseases, Dengue Branch, SanJuan, Puerto Rico 00920.
authors.forename: Kovi
authors.initials: K
authors.lastname: Bessoff
authors.forename: Mark
authors.initials: M
authors.lastname: Delorey
authors.forename: Wellington
authors.initials: W
authors.lastname: Sun
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hunsperger
mesh_terms: D003715:Dengue / Q000175:diagnosis*; D003716:Dengue Virus / Q000302:isolation & purification*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D017361:Viral Nonstructural Proteins; D014773:Virology / Q000379:methods*
chemical_list: D007074:Immunoglobulin G; D017361:Viral Nonstructural Proteins