Amplified DNA Assays Detect Chlamydia Trachomatis and Neisseria Gonorrhoeae

New technology provides clinical laboratories with extremely reliable detection of Chlamydia trachomatis and Neisseria gonorrhoeae at a high throughput rate using internal extraction control and process verification.

BD Diagnostics (Franklin Lakes, NJ, USA), a segment of BD (Becton, Dickinson and Company) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) 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.

When tested with the BD Viper System with XTR technology, the BD ProbeTec CT Qx and GC Qx amplified DNA assays use BD ferric oxide, FOX Extraction, and strand displacement amplification technologies for the direct, qualitative detection of Chlamydia and Neisseria DNA.

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.

The tests are performed on clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. These assays are indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial and gonococcal urogenital disease.

BD is a leading global medical technology company that develops, manufactures, and sells medical devices, instrument systems, and reagents. The company is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery, and production of new drugs and vaccines.

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BD Diagnostics
U.S. Food and Drug Administration