title: A two-site analytical evaluation of the BD Viper System with XTR Technology in Nonextracted Mode and Extracted Mode with seeded simulated specimens.
abstract: The BD ProbeTec CT Q(x) Amplified DNA Assay and the BD ProbeTec GC Q(x) Amplified DNA Assay (both BD Diagnostics, Sparks, MD) represent two new assays developed for use with the BD Viper System with XTR Technology (BD Diagnostics). These assays were built on the foundation of the former BD ProbeTec ET assays (BD Diagnostics) and its accompanying instrumentation. The study described below compared the new assay format, Extracted Mode, to the former assay format, Nonextracted Mode, with the primary objective of examining and measuring overall time expenditures and efficiency of operation. An 80-142-min reduction in "hands-on" total processing time was observed for the Extracted Mode whether testing urines or swabs. The second objective was to assess the accuracy of performance at low simulated analytical loads for the pathogens Chlamydia trachomatis and Neisseria gonorrhoeae. Performance accuracies for simulated positive and negative urine or swab specimens were calculated to be 99.97% for Extracted Mode and 99.76% for Nonextracted Mode.
authors.affiliation: Medical Affairs, BD Diagnostic Systems, 7 Loveton Circle, MC 662, Sparks, MD 21152, USA. elliot_rank@bd.com
authors.forename: Elliot L
authors.initials: EL
authors.lastname: Rank
authors.forename: Robert L
authors.initials: RL
authors.lastname: Sautter
authors.forename: Kathleen G
authors.initials: KG
authors.lastname: Beavis
authors.forename: Sharon
authors.initials: S
authors.lastname: Harris
authors.forename: Sharon
authors.initials: S
authors.lastname: Jones
authors.forename: Rebecca
authors.initials: R
authors.lastname: Drechsel
authors.forename: Beth
authors.initials: B
authors.lastname: Goad
authors.forename: Michelle
authors.initials: M
authors.lastname: Althouse
mesh_terms: D057205:Automation, Laboratory / Q000295:instrumentation / Q000379:methods*; D015373:Bacterial Typing Techniques / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D002584:Cervix Uteri / Q000382:microbiology; D002692:Chlamydia trachomatis / Q000302:isolation & purification; D004269:DNA, Bacterial / Q000032:analysis / Q000302:isolation & purification; D005260:Female; D006801:Humans; D008297:Male; D009344:Neisseria gonorrhoeae / Q000302:isolation & purification; D021141:Nucleic Acid Amplification Techniques / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D015203:Reproducibility of Results; D013997:Time Factors; D014521:Urethra / Q000382:microbiology; D014556:Urine / Q000382:microbiology
chemical_list: D004269:DNA, Bacterial