title: Multicenter study of clinical performance of the 3M Rapid Detection RSV test.
abstract: This multicenter study evaluated the clinical performance of the 3M Rapid Detection RSV test (3MRSV) compared to a composite reference standard of R-Mix culture and direct specimen immunofluorescence for detection of respiratory syncytial virus (RSV). The performance of the BinaxNOW RSV test was also evaluated using this reference standard. In a secondary analysis, discordant results were arbitrated using the Gen-Probe/Prodesse ProFlu+ reverse transcription-PCR (RT-PCR) assay. Subjects were stratified into three groups as follows: group 1 (G1), all ages; G2, subjects <22 years old (FDA-cleared ages for 3MRSV testing); and G3, subjects <5 years old (FDA-cleared ages for BinaxNOW RSV testing). A total of 1,306 specimens (G1, n = 1,306; G2, n = 1,140; G3, n = 953) from subjects of all ages presenting with respiratory symptoms met study criteria for analysis. Sensitivities, specificities, positive predictive values, and negative predictive values of 3MRSV for G1 were 86.5%, 95.8%, 91.4%, and 93.2%, respectively, and those for G2 were 87.3%, 95.6%, 92.4%, and 92.5%, respectively. For those samples analyzed by both 3MRSV and BinaxNOW, the 3MRSV was more sensitive (G1, 86.3%; G2, 87.2%; and G3, 89.9%) than was BinaxNOW (G1, 70.84%; G2, 72.0%; and G3, 72.4%) (P < 0.05). Specificities for RSV detection from nasopharyngeal (NP) aspirates and NP swabs for all groups were comparable for 3MRSV and BinaxNOW, but 3MRSV was less specific than BinaxNOW when nasal washes/aspirates were tested (P < 0.05). The 3MRSV assay performed well for the detection of RSV, and the overall assay performance was superior to that of BinaxNOW. The 3MRSV reader eliminated user misinterpretation and provided test result and quality control documentation.
authors.affiliation: North Shore-Shore-Long Island Jewish Health System Laboratories, Lake Success, NY 11042, USA. cginocch@nshs.edu
authors.forename: Christine C
authors.initials: CC
authors.lastname: Ginocchio
authors.forename: Ella
authors.initials: E
authors.lastname: Swierkosz
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: McAdam
authors.forename: Mario
authors.initials: M
authors.lastname: Marcon
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Storch
authors.forename: Alexandra
authors.initials: A
authors.lastname: Valsamakis
authors.forename: Stefan
authors.initials: S
authors.lastname: Juretschko
authors.forename: José
authors.initials: J
authors.lastname: Romero
authors.forename: Belinda
authors.initials: B
authors.lastname: Yen-Lieberman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000956:Antigens, Viral / Q000032:analysis*; D012634:Bodily Secretions / Q000821:virology; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007223:Infant; D007231:Infant, Newborn; D008168:Lung / Q000821:virology; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic / Q000821:virology; D018357:Respiratory Syncytial Virus Infections / Q000175:diagnosis*; D012136:Respiratory Syncytial Viruses / Q000302:isolation & purification*; D018709:Statistics, Nonparametric; D013997:Time Factors
chemical_list: D000956:Antigens, Viral; D011933:Reagent Kits, Diagnostic
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