Multiplex assay for 10 sexually transmitted infections receives CE marking

CE marking has been granted to one of the most comprehensive cartridge-based STI tests.

The test, developed by the UK’s largest health diagnostics company, Randox Laboratories, tests simultaneously for 10 of the most common sexually transmitted infections, on the firm’s patented Biochip Technology.

Quickly and efficiently testing for multiple STIs, which often have mild symptoms if any at all, ensures early diagnosis at a stage when treatment is most successful, supports the targeted use of antibiotics, and ultimately reduces their mishandling.

Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;

“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. The CE marking of the STI assay, which incorporates Randox Biochip Technology, will be a game-changer for clinicians and patients across Europe, by facilitating early, accurate and comprehensive diagnoses of STIs that allows for the best possible patient outcome. Never before has there been this level of accessibility and speed with regards to STI testing.”

The Randox STI assay is performed on the Vivalytic system, an intuitive point-of-care platform, developed in partnership with German technology company Bosch that provides the broadest range of test options ever seen for an analyser of its size.

Harnessing the application of multiplex assays to provide greater information from a single patient sample, the Vivalytic simplifies the testing process for otherwise complex laboratory testing procedures.

Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said:

“We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”

Benefits of the Randox STI assay technology on the Vivalytic system

• Fully automated, cartridge-based molecular diagnostics.
• Multiplex technology detects multiple STIs, including co-infections, from a single patient sample.
• Full molecular workflow of extraction, PCR amplification and detection.
• A hygiene and space-saving all-in-one solution that does not require additional peripherals such as laptop, keyboard, barcode scanner or filling stations.
• Ultimate protection of data and valuable sample material thanks to integration of software with instrument that ensures a safe and reliable run.
• Test results can be presented either in summary or in detailed raw data form.
• Instantly available results due to easy integration with popular standard IT systems.

The assay tests simultaneously, from one patient sample, for the STIs below;

• Chlamydia trachomatis (CT)
• Neisseria Gonorrhoeae (NG)
• Trichomonas vaginalis (TV)
• Mycoplasma genitalium (MG)
• Treponema pallidum (syphilis) (TP)
• Herpes simplex virus 1 (HSV-1)
• Herpes simplex virus 2 (HSV-2)
• Haemophilus ducreyl (HD)
• Mycoplasma hominis (MH)
• Ureaplasma urealyticum (UU)

For further information please contact the Randox PR team on 028 9442 2413 or email randoxpr@randox.com