Articles & Experts

Multiplex assay for 10 sexually transmitted infections receives CE marking

Monday, March 09, 2020

by Randox Laboratories Ltd.


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.

Notes to Editors

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)


Contact Information

For more information or to arrange interviews, please contact the Randox PR team on (0) 28 9442 2413 or email


Press contact Bosch Healthcare Solutions:

Thomas Berroth

Marketing & Communication

+49 (0) 711 805-4436


About Randox Laboratories

Randox is a global leader in healthcare diagnostics; today more than 5% of the world’s population – in excess of 370 million people across 145 countries – receives medical diagnosis using Randox products each year. Randox is the largest diagnostic company from the UK and exports over 95% of products worldwide. Our products and services are used in hospitals, clinical, research and molecular laboratories, food testing, forensic toxicology, life sciences, and veterinary laboratories.

With more than 1500 employees of 44 nationalities, including 430 research scientists and engineers, we have offices and distribution in over 145 countries. There are four key manufacturing and research and development sites, located in County Antrim, Northern Ireland; Dungloe, County Donegal, Ireland; Bangalore, India; and one in development in the Greater Washington DC area, USA. Our Randox Health Clinics are currently located in London and Belfast, with ambitious plans to roll out a number of new clinics in the coming months and years. A mobile service enabling certified Randox Health staff to visit clients at their convenience has also been launched.

With a major focus in R&D, Randox scientists work in pioneering research into a range of common illnesses such as cancer, cardiovascular disease and Alzheimer’s disease. With up to 25% of turnover reinvested in R&D, Randox has more new tests in development than any other diagnostic company.

Our scientists have spent over £305 million researching the thousands of biomarkers present in our bodies and have identified the gold standard in testing. Our patented Biochip Array Technology is the world’s only diagnostic grade biochip. This state-of-the-art technology has revolutionised the diagnostics industry by offering a unique testing platform which allows multiple tests to be carried out from a single patient sample at our Randox Health Clinics.


About Bosch Healthcare Solutions

Bosch Healthcare Solutions GmbH is a wholly owned subsidiary of Robert Bosch GmbH. The subsidiary was established in 2015 with the aim of developing products and services that improve people’s health and quality of life. About 120 associates are currently employed at the company’s headquarters in Waiblingen, Germany. The subsidiary’s solutions draw on the Bosch Group’s core competencies: sensors to collect data, software to evaluate that data, and services based on this data analysis.


Randox Laboratories Ltd.