BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announces that it has received 510(k) clearance from the FDA for the BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay and the BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the next-generation BD Viper™ System with XTR™ technology.
The BD Viper System with XTR Technology enables laboratories to process a higher volume of tests automatically from swabs or urine samples, with significantly less labor and more reliable test results. This improvement in process efficiency may lead to a higher number of accurate diagnoses and more appropriate patient care for the two most common sexually transmitted infections – Chlamydia and gonorrhea. If left untreated, these infections in women can lead to pelvic inflammatory disease, infertility, ectopic pregnancy and chronic pelvic pain.
“BD ProbeTec Qx Amplified DNA Assays are designed to meet the needs of today’s high-volume clinical laboratories, providing extremely reliable detection of Chlamydia trachomatis and Neisseria gonorrhoeae,” said Gregory Meehan, Vice President of BD Diagnostics – Diagnostic Systems, Molecular Diagnostics. “Running these advanced molecular assays on the BD Viper System with XTR Technology offers laboratories total system integrity that helps assure reliability in their systems, reagents and results.”
The fully automated system processes up to 736 patient samples in a single work shift. It offers the least hands-on time for setup, sample extraction, workflow, and maintenance. One operator can fully execute all of the functions required to report results with several BD Viper Systems operating concurrently.
Source: Becton, Dickinson and Company