The process of detecting two of the most common sexually transmitted infections – Chlamydia and gonorrhea– may have just become more efficient.
BD Diagnostics (Baltimore, Maryland), a segment of Becton, Dickinson and Company, said it has received FDA 510(k) clearance for its BD ProbeTec Chlamydia trachomatis Qx Amplified DNA Assay and the BD ProbeTec Neisseria gonorrhoeae Qx Amplified DNA Assay on the next-generation BD Viper system with XTR technology. BD is launching the new assays this week.
According to the company, the BD ProbeTec Qx assays are designed to make the process of detecting chlamydia and gonorrhea more efficient and the diagnoses more accurate. The BD Viper system with XRT technology enables laboratories to process a higher volume of tests automatically from swabs or urine samples, with significantly less labor and more reliability, BD noted.
German Nunez, worldwide product manager for BD Viper Systems, told Medical Device Daily that he believes these new assays require the least amount of hands on time in the laboratory for setup, sample extraction, workflow and work shift, compared with other available assays for these indications.
According to BD, the fully automated system processes up to 736 patient samples in a single work shift. One operator can fully execute all of the functions required to report results with several BD Viper Systems operating concurrently, the company said.
"The user in the laboratory does not have to spend a lot of time preparing the agent, they can just load them," Nunez said. "It takes 10 minutes of hands on time, this is unique in this type of molecular testing."
According to BD, Chlamydia and gonorrhea are the two most common sexually transmitted infections. The World Health Organization (Geneva, Switzerland) estimates that 92 million new cases of Chlamydia and 62 million new cases of gonorrhea are diagnosed each year. 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, VP 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 new BD Viper system with XTR technology is designed to provide high-volume customers with highly reliable detection of Chlamydia and gonorrhea at a high throughput rate using an internal extraction control and process verification.
When tested with the BD Viper system with XTR technology, the BD ProbeTec CT Qx and GC Qx Amplified DNA 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), 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.
"It's a very unique system that has been well received by all the users," Nunez said.