title: Evaluation of respiratory syncytial virus (RSV) direct antigen detection assays for use in point-of-care testing.
abstract: RSV infections cause lower respiratory tract infections and result in surges in physician's office, emergency department visits and hospitalizations, especially in infants and toddlers. Point-of-care (POC) testing reduces healthcare costs and permits informed decisions on treatment, however, optimal POC assays must be sensitive, easy to perform and provide rapid results. A prospective study tested 230 patient nasopharyngeal specimens using 4 RSV direct antigen detection assays (Directigen, Quickvue, Sofia and Veritor) and RT-PCR. A RSV dilution study was also performed to evaluate sensitivity. RSV fluorescent antibody testing in 46/230 patients was also evaluated. Sensitivity values obtained for the Sofia, Veritor, Directigen and Quickvue assays (%) were 85, 72.5, 70 and 57.5, respectively. Fluorescent result interpretation may account for Sofia's enhanced sensitivity. Specificity (%) was 97-100 among assays. Sensitivity data were confirmed in the dilution studies. Fluorescent antibody testing demonstrated 64% sensitivity compared with RT-PCR. Objective result reporting, walk away testing and high sensitivity make the Sofia a valuable choice for POC testing. Veritor's sensitivity may also render it acceptable in POC. Lack of objective results by Directigen and the poor sensitivity observed by Quickvue may preclude their value in diagnostic testing.
authors.affiliation: Virology Laboratory, Department of Pathology & Laboratories, Nassau University Medical Center, 2201 Hempstead Turnpike, Box, 47, East Meadow, NY 11554, United States. Electronic address: leonardi@numc.edu.
authors.forename: G P
authors.initials: GP
authors.lastname: Leonardi
authors.affiliation: Virology Laboratory, Department of Pathology & Laboratories, Nassau University Medical Center, 2201 Hempstead Turnpike, Box, 47, East Meadow, NY 11554, United States.
authors.forename: A M
authors.initials: AM
authors.lastname: Wilson
authors.affiliation: Virology Laboratory, Department of Pathology & Laboratories, Nassau University Medical Center, 2201 Hempstead Turnpike, Box, 47, East Meadow, NY 11554, United States.
authors.forename: M
authors.initials: M
authors.lastname: Dauz
authors.affiliation: Virology Laboratory, Department of Pathology & Laboratories, Nassau University Medical Center, 2201 Hempstead Turnpike, Box, 47, East Meadow, NY 11554, United States.
authors.forename: A R
authors.initials: AR
authors.lastname: Zuretti
mesh_terms: D000328:Adult; D000368:Aged; D000956:Antigens, Viral / Q000032:analysis*; D002675:Child, Preschool; D005260:Female; D019085:Fluorescent Antibody Technique, Direct / Q000379:methods*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D011446:Prospective Studies; D018357:Respiratory Syncytial Virus Infections / Q000175:diagnosis*; D012136:Respiratory Syncytial Viruses / Q000276:immunology / Q000302:isolation & purification*; D012680:Sensitivity and Specificity
chemical_list: D000956:Antigens, Viral
keywords: Antigen detection; Point of care; Respiratory syncytial virus