BD's two new molecular diagnostic reagents are FDA and CE certified

Recently, BD Global Diagnostics Systems announced that BD ProbeTec and the Neisseria gonorrhoeae Qx DNA amplification test molecular diagnostic reagents have been certified by the US FDA and the EU CE/IVD mark. The approved reagents will pass BD Viper LT. The system enters the market.

The BD Viper LT system is a benchtop molecular platform that automates sample processing, nucleic acid extraction, real-time polymerase chain reaction (RT-PCR) amplification assays, and results reporting, minimizing human intervention. The BD Viper LT system handles sample tubes with piercing closures and ready-to-use reagents. The ability to “inject and execute” and easy-to-operate design can truly bring “unattended” possibilities and dramatically increase lab productivity.

The combination of the BD Viper LT system and ProbeTec's eye chlamydia and gonococcal assays provides innovative solutions for microbiology and molecular laboratories, enhancing clinical applications, increasing flexibility and increasing laboratory efficiency. This increased processing efficiency increases the accuracy of the diagnosis and provides more appropriate disease management for the two most common sexually transmitted infections, chlamydia and gonorrhea. If not treated promptly, these two infectious diseases can cause women with pelvic inflammatory disease, infertility, ectopic pregnancy and chronic pelvic pain.

"The BD Viper LT System and BD ProbeTecQx DNA Amplification Test are designed to meet the needs of today's clinical laboratories, using all types of genital tract samples to automatically, accurately and reliably detect Chlamydia trachomatis and Neisseria gonorrhoeae," BD Global Vice President Doug White, general manager of the Women's Health Department of the Diagnostic System, said.

According to estimates by the World Health Organization, about 105.7 million cases of chlamydia and 106.1 million gonorrhea patients are added each year worldwide. In the United States, chlamydia is the most common sexually transmitted disease caused by bacteria. According to estimates by the US Centers for Disease Control and Prevention, approximately 2.86 million people in the United States are infected with chlamydia, and about 820,000 gonorrhea patients are added each year.