29th July 2014 Content supplied by: BD Diagnostic Systems
CE/IVD Marking for BD Viper™ LT Chlamydia and Gonorrhea Assays
BD Diagnostics has achieved CE/IVD marking for the BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay and the BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the BD Viper™ LT System.
The BD Viper LT System is a bench-top molecular platform that automates sample liquid handling, nucleic acid extraction, amplification, detection and result reporting without any user intervention. The BD Viper LT System is designed to manage primary sample tubes with pierceable caps and ready to use reagents. This “load and go” reagent and sample capability along with the easy to use design of the BD Viper LT System delivers true walkaway time to the laboratorian and maximizes productivity.
The combination of the BD Viper LT System and the BD ProbeTec Chlamydia trachomatis (CT) Qx and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assays brings an innovative solution to microbiology and molecular labs that increases flexibility and improves laboratory efficiency.
The new BD Viper LT System is designed to provide low and mid-volume laboratories with highly reliable detection of Chlamydia and gonorrhea from all genital sample types on an automated and easy to use platform. When tested with the BD Viper LT System, the BD ProbeTec Qx Assays use BD proprietary ferric oxide, FOX™ Extraction, and Strand Displacement Amplification technologies for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA. The tests are performed on clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), male and female urine specimens (neat and UPT) and gynecological specimens collected in BD SurePath™ Preservative Fluid or PreservCyt™ Solution. These assays are indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial and gonococcal urogenital disease.
Date Published: 29th July 2014