Multiplex STI assay for 10 sexually transmitted infections receives CE marking
Multiplex STI assay for 10 sexually transmitted infections receives CE marking
02 March 2020
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
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Hospitals in Wuhan and Guangzhou roll out new coronavirus test developed by Randox scientists
02 March 2020
Hospitals in Wuhan and Guangzhou roll out new coronavirus test developed by Randox scientists
Randox’s pioneering new test for coronavirus, which identifies COVID-19 and differentiates it from nine other respiratory infections, is to be used in Chinese hospitals.
The comprehensive test, which is being shipped this week to hospitals in Wuhan and Guangzhou, has been developed on Randox’s unique technology platform, the Biochip. This allows for each patient to be simultaneously tested for a range of respiratory infections inclusive of all known coronaviruses.
The Coronavirus Biochip tests each single patient sample for the SARS-CoV-2 virus that causes COVID-19, as well as nine other respiratory viruses, including SARS, MERS, and Influenza A and B. This enables clinicians to quickly and efficiently differentiate between potentially lethal and non-lethal infections, prioritise patients and administer appropriate and timely treatment.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Current technologies being used to diagnose COVID-19 are focused on simply detecting the presence or lack of this singular strain and therefore neglect to differentiate it from other respiratory infections. At Randox we have developed a multiplex Viral Respiratory Infection Array that tests for COVID-19 and nine other infections simultaneously, and are delighted that this new technology will be deployed in Wuhan and other cities across China.
“The Coronavirus Biochip will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found, thereby empowering clinicians to make faster and better-informed decisions.”
Due to be used in hospitals in Wuhan, the epicentre of the coronavirus outbreak, as well as in The First Affiliated Hospital of Guangzhou Medical University, the new testing technology is capable of processing 324 patient samples, generating 3240 reportable results, in just 8 hours.
The panel includes two tests for COVID-19, a specific test (SARS-CoV-2) and a confirmatory test (Sarbecoviris) on the same panel, as recommended by the World Health Organisation. This avoids the need to repeat the test, and importantly, reduces the likelihood of incorrect diagnosis, ensuring appropriate containment and reducing the risk of further contamination. This faster and more comprehensive testing will ultimately support the health service in China by facilitating the efficient use of valuable healthcare resources.
Byron Wang, CEO of Beijing Promed, Randox’s partner in providing the new coronavirus test in China, commented;
“We welcome the support of the global community in assisting us combat COVID-19 at this time. Randox is a highly regarded In Vitro Diagnostic company in China and has supported our market with high quality products for many years. We look forward to supplying this test to hospitals located within the area of greatest need and believe it will make a real difference.”
Dr FitzGerald concluded;
“Randox is committed to saving and improving lives on a global scale and we know that this new COVID-19 test will make a significant contribution to the global coronavirus containment effort.”
The Coronavirus Biochip tests simultaneously for Coronavirus SARS-CoV-2 (COVID-19), Sarbecoviris (SARS, SARS like, COVID-19), Coronavirus 229E/NL63, Coronavirus OC43/HKUI, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Adenovirus A/B/C/D/E, Enterovirus A/B/C, Influenza A, Influenza B and Rhinovirus A/B.
The Randox Coronavirus Biochip complies with guidelines from the Centres for Disease Control and Prevention and the World Health Organisation.
For more information or to arrange interviews, please contact the Randox PR team on 028 9442 2413 or email randoxpr@randox.com
