The assays are for detecting Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis from a single specimen in one run. Urine samples can be used for testing, as well as self-collected vaginal swabs and clinician-collected endocervical swabs, BD said. Once loaded onto the BD Max platform, results can be generated in less than three hours.
The BD Max system combines automated extraction, real-time PCR amplification, and detection.
CT, GC and TV are among the most prevalent sexually transmitted infections (STIs). The World Health Organization estimates that globally 105.7 million new cases of infection due to Chlamydia trachomatis, 106.1 million new cases of infection due to Neisseria gonorrhoeae and 27.4 million new cases of Trichomonas vaginalis occur annually. These infections can have serious consequences if left unaddressed, such as pelvic inflammatory disease, ectopic pregnancy, infertility, pre-term or low birth-weight babies and increased risk of STI transmission or infection (including HIV) in males and females.
"We're pleased to be able to offer customers the convenience and performance of our BD MAX CT/GC/TV and CT/GC assays along with the capabilities of our fully automated BD MAX platform,” said Doug White, vice president and general manager of Molecular Diagnostics and Women’s Health at BD Life Sciences – Diagnostic Systems. “We are dedicated to expanding the BD MAX portfolio with clinically relevant assays that help enable our customers to improve clinical outcomes while providing enhanced workflow and efficiency in the clinical laboratory.”
The BD MAX System combines and automates real-time PCR (polymerase chain reaction) extraction, amplification and detection and into a single platform capable of running both U.S. Food and Drug dministration-cleared and open-system assays.
BD serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. The Franklin Lakes, N.J.-based firm manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products.