title: Head-to-head comparison of the diagnostic accuracies of BD Veritor™ System RSV and Quidel® Sofia® RSV FIA systems for respiratory syncytial virus (RSV) diagnosis.
abstract: BACKGROUND
  Respiratory syncytial virus (RSV) is one of the most common causes of severe lower respiratory tract disease among infants and young children. BD Veritor™ System RSV (BD) and Quidel(®) Sofia(®) RSV FIA (QD) are the new generation lateral flow digital immunoassay (DIA) tests with an instrumented read for the qualitative detection of RSV viral antigens.
  
  
  OBJECTIVE
  To compare the diagnostic accuracies of BD and QD for RSV detection using fresh nasopharyngeal aspirates and nasopharyngeal swab specimens collected in universal transport media during 2013-2014 respiratory season.
  
  
  METHODS
  The two DIA tests were performed simultaneously on randomly selected specimens on a weekly basis during the RSV season until 200 fresh remnant specimens were enrolled. Real-time RT-PCR assay results were used to compare and evaluate the performance of both RSV DIA assays.
  
  
  RESULTS
  Among 200 specimens tested, RSV real-time RT-PCR assay detected RSV in 104 samples, while QD detected 84 samples and BD detected 74 samples as positive. The overall sensitivity for detection of RSV in comparison to PCR was 71.15% (61.3-79.4) for BD and 80.77% (71.6-87.6) for QD system (P=0.36). The specificity was 100% (95.2-100) for both systems. The work flow analysis revealed that the overall specimen processing time was significantly lower for BD as compared with the QD assay.
  
  
  CONCLUSIONS
  In comparison with the real-time PCR, the QD system showed a higher sensitivity than that of the BD system, but the difference did not reach statistical significance (P=0.36). Both BD and QD systems were found comparable in terms of specificity.
authors.affiliation: Department of Pathology and Laboratory Medicine, Children's Mercy Hospital and Clinics, Kansas City, MO 64108, USA.
authors.forename: Neena
authors.initials: N
authors.lastname: Kanwar
authors.affiliation: Department of Pathology and Laboratory Medicine, Children's Mercy Hospital and Clinics, Kansas City, MO 64108, USA; University of Missouri, School of Medicine, Kansas City, MO 64108, USA.
authors.forename: Ferdaus
authors.initials: F
authors.lastname: Hassan
authors.affiliation: Department of Pathology and Laboratory Medicine, Children's Mercy Hospital and Clinics, Kansas City, MO 64108, USA.
authors.forename: Ashley
authors.initials: A
authors.lastname: Nguyen
authors.affiliation: Department of Pathology and Laboratory Medicine, Children's Mercy Hospital and Clinics, Kansas City, MO 64108, USA; University of Missouri, School of Medicine, Kansas City, MO 64108, USA. Electronic address: rselvarangan@cmh.edu.
authors.forename: Rangaraj
authors.initials: R
authors.lastname: Selvarangan
mesh_terms: D000293:Adolescent; D000956:Antigens, Viral / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007223:Infant; D008297:Male; D009305:Nasopharynx / Q000821:virology; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D018357:Respiratory Syncytial Virus Infections / Q000175:diagnosis*; D012136:Respiratory Syncytial Viruses / Q000276:immunology / Q000302:isolation & purification*; D012141:Respiratory Tract Infections / Q000175:diagnosis*; D012680:Sensitivity and Specificity; D013048:Specimen Handling
chemical_list: D000956:Antigens, Viral
keywords: BD Veritor™ System RSV; Quidel(®) Sofia(®) RSV FIA system; RT real time PCR; Rapid antigen testing; Respiratory syncytial virus; Sensitivity; Specificity