BD Diagnostics has announced it 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.
Viper LT System is designed to manage primary sample tubes with pierceable caps and ready to use reagents. The ‘load and go’ reagent and sample capability, along with the easy to use design of the system maximizes productivity.
Combining the Viper LT System, the ProbeTec chlamydia trachomatis (CT) Qx and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assays is an innovative solution to microbiology and molecular labs, by increasing flexibility and laboratory efficiency.
Improved efficiency provides timely diagnostic information to clinicians for more effective patient management of two of the most common sexually transmitted bacterial infections, chlamydia and gonorrhea.
If left untreated, these infections can lead to pelvic inflammatory disease, infertility, ectopic pregnancy and chronic pelvic pain.
BD Diagnostics vice-president and general manager of Molecular Diagnostics and Women’s Health Doug White said: "The BD Viper LT system and the BD ProbeTec Qx Amplified DNA Assays are designed to meet the needs of today’s clinical laboratories, providing automated, accurate and reliable detection of Chlamydia trachomatis and Neisseria gonorrhoeae, for all genital sample types."
The 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 female endocervical and male urethral swab specimens and patient-collected vaginal swab specimens, in a clinical setting.
In addition, tests are performed on 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.