Sexually Transmitted Infections – Rapid Testing at the Point of Care
Urgency, Challenges and Advances in STI Testing
Sexually transmitted infections (STIs) are a major global health issue, with over 30 pathogens causing an estimated one million infections daily, a number that is rising. Surveillance programs in countries like the United States and Canada have reported an increase in STIs such as syphilis, gonorrhoea, and chlamydia. STIs can have serious consequences for sexual health, including infertility and chronic pelvic pain, particularly affecting women. The World Health Organization (WHO) has recognised the urgency of addressing this problem and has recommended measures to end the STI healthcare issue by 2030. Integrated testing, including multiplex and point-of-care testing, is considered essential. However, implementation of these recommendations at regional and national levels is lacking. Rapid point-of-care PCR tests that can detect multiple pathogens simultaneously would greatly improve STI diagnosis and containment. Currently, Randox, in collaboration with Bosch offers two STI test panels on the Vivalytic POC system: Vivalytic STI and Vivalytic MG, MH, UP/UU panels, capable of detecting multiple pathogens in a single test run, with results available within hours.
The Global Burden
- The WHO estimates 374 million new infections of chlamydia, gonorrhoea, syphilis, and trichomoniasis annually.
- Chlamydia is the most frequently reported STI in Europe, followed by gonorrhoea and syphilis.
- Countries with comprehensive STI screening programs, like Denmark, have higher prevalence rates than the European average.
- The UK has a comprehensive screening program for chlamydia targeting 15-24-year-olds, with cases accounting for 60% of total cases in the European Region.
- The actual infection rate in countries without systematic screening is likely higher than official figures suggest.
- Reported cases of gonorrhoea and syphilis in the European Region have increased, particularly among certain age groups and higher numbers in men than women.
Gaps in Current STI Testing Strategies
The European Centre for Disease Prevention (ECDC) acknowledges the growing concern of STIs in Europe and emphasises the importance of testing in their recent report. While various European countries have screening programs for chlamydia, testing options for other STI pathogens are usually limited. The lack of accessible testing, combined with the prevalence of asymptomatic infections, increases the risk of STI transmission and hampers containment efforts. Prevention campaigns and low-threshold testing opportunities are crucial to address the spread of STIs. The UK’s chlamydia screening program, implemented in 2008, demonstrated the benefits of community-based testing services and led to a significant increase in diagnosed cases, reducing the number of unreported cases.
Infections and Co-Infections
- Co-infections, where multiple sexually transmitted pathogens are present simultaneously, are common but often go undetected due to limited testing.
- Symptoms of co-infections can be difficult to differentiate since different pathogens can cause similar or overlapping symptoms.
- However, most STIs, even in high-risk groups, are caused by a single sexually transmitted pathogen.
- In cases where co-infections need to be detected, a rapid and comprehensive differential diagnosis of sexually transmitted pathogens is crucial for initiating appropriate therapy promptly.
The Importance of Rapid Results at the Point of Care
- Rapid detection and treatment of STIs are crucial to prevent further spread.
- Traditional STI diagnostics in specialized laboratories can result in delays of several days or up to 1-2 weeks until test results are available to the physician.
- Delays occur due to transportation of samples, laboratory workflow, result transfer, and scheduling additional appointments.
- The delay in treatment initiation can lead to decreased patient compliance and missed appointments.
The Vivalytic STI test provides results directly at the point of care (POC) in less than two and a half hours. It eliminates the need for sample transportation to a central laboratory. In addition, patients can receive their test results on the same day of the visit, allowing for immediate initiation of appropriate treatment.
In a Nutshell
Sexually transmitted infections (STIs) spread due to various factors. Many STIs do not show symptoms, resulting in numerous unreported and untreated cases that can have fatal consequences depending on the specific pathogen. Increasing awareness and implementing a decentralised low-threshold testing strategy can significantly reduce infections, particularly among high-risk groups. Speed and comprehensive testing of relevant pathogens are crucial for targeted therapy and containing STIs. Rapid PCR tests used at the point of care (POC) are emerging as important technologies due to their advantages. Patients receive same-day results and immediate treatment, providing clarity in just one visit. Clinicians can provide up-to-date diagnoses and treatments, even in decentralised or hospital settings, benefiting high-risk patients with limited access to healthcare.
The Bosch Vivalytic, is an advanced and automated platform for molecular diagnostics that utilises PCR to detect pathogens. It offers applications for various medical disciplines and requires only a few steps from sample collection to obtaining results. The patient sample is processed automatically within the Vivalytic analyser, and the test result is displayed on its integrated screen. The time it takes to get results depends on the specific Vivalytic application. For the STI Panel, which simultaneously detects 10 common sexually transmitted pathogens, the time to result is 2.5 hours. On the other hand, the Vivalytic MG, MH, UP/UU panel, used to detect mycoplasmas and/or ureaplasmas, provides results in approximately one hour.
By conducting fully automated analyses at the point of care, Vivalytic saves valuable time for hospitals, labs, genitourinary clinics and doctor’s offices during their routine processes.
|STI Panel||MG, MH, UP, UU Panel|
|Chlamydia trachomatis||Mycoplasma genitalium|
|Neisseria gonorrhoeae||Mycoplasma hominis|
|Trichomonas vaginalis||Ureaplasma parvum/Ureaplasma|
|Herpes simplex virus I|
|Herpes simplex virus II|
At a Glance
- The Vivalytic system allows fully automated sample analysis with minimal manual steps.
- It eliminates the need for expensive and complex laboratory equipment.
- Vivalytic supports both single and multiplex tests.
- The Vivalytic does not require peripheral equipment such as a laptop, keyboard, barcode scanner, or charging station.
- The cartridge used in the system ensures hygienic and safe operation as a closed system.
- Cartridges can be stored and used at room temperature.
- Vivasuite, a cloud-based solution, facilitates convenient device management.
- The Vivalytic can be seamlessly integrated into existing IT structures using HL7, Ethernet, USB, or WLAN.
Randox Health have entered into an exciting new partnership with REVIV
Randox Health Clinics are pioneering preventative health care, bringing the world’s most advanced and personalized health programs directly to the public – with the goal of harnessing the power of testing and data to shift healthcare away from sickness management and towards a more proactive approach.
This partnership with REVIV, who championed commercialised IV therapy, will allow people to see real-time results from taking steps to protect their health and to experience the future of wellness.
The IVD drip therapies include:
- The Megaboost, that was designed with wellness in mind this infusion is packed with B vitamins, Vitamin C, Antioxidants and minerals to accomplish restoration of the body’s essential nutrients in one drip.
- The Miniboost, similar to its larger counterpart, the Megaboost, this Miniboost is not to be underestimated! Containing B Vitamins, Vitamin C and antioxidants, it can support energy levels and the immune system whilst aiding protection against cell-damaging free radicals.
- The Royal Flush which supercharges recovery and nutritional balance by providing the ingredients you need directly into your bloodstream. This all-in-one infusion has been directly designed to rehydrate, decreame inflammation and aid detoxification.
- The Hydromax IV which aims to replenish your body’s salts and water.
- The Vitaglow can support detoxification of free radicals that accumulate in the body from exposure to pollutants, daily stresses and chemicals including pesticides.
- The Ultraviv and The Ultraviv pro, both recovery infusions. The Ultraviv can be used to aid recovery against the common cold, sore throats and even the after effects of alcohol. The Ultraviv pro combines a number of prescribed medications with essential vitamins and nutrients delivered alongside the maximum of hydration.
On REVIV partnering with Randox, David Ferguson, Chief Operating Officer, said: “Over the past few years, we’ve seen a dramatic change in people’s behaviours as they seek to understand their health and wellbeing better. At Randox Health, we provide a range of specialised health packages that enable you to take control of your health.
“Our innovative diagnostic technologies can deliver hundreds of results to give you a comprehensive overview of your health and help detect the earliest signs of illness. Collaborating with REVIV is a natural next step, combining our world-class diagnostic services with REVIV signature IV therapies to help our customers protect their current and future health.”
Randox invests £30m and 200 new jobs in specialised COVID-19 testing lab
As part of efforts to enhance its national testing capacity, global diagnostics company Randox has announced an investment of £30m in a new specialised COVID-19 testing hub.
The healthcare firm, which is currently conducting COVID-19 tests as part of the national testing programme, announced its investment in the new facilities based at the Randox Science Park in Antrim, Northern Ireland, during a visit yesterday by the Secretary of State for Northern Ireland, The Rt Hon Brandon Lewis CBE.
The specialised laboratory, the development of which was fast-tracked over the space of four weeks, is the first step in a wider diagnostics investment programme from Randox.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“The national testing programme, as a collaborative effort by government and various partners within industry, has increased testing capacity at an unparalleled speed – by installing a network of drive-through testing centres, introducing home testing kits, and now, opening this specialised lab at the Randox Science Park in Northern Ireland.
“An incredible amount of work has gone into making this cutting-edge testing facility a reality in a relatively short space of time, as we know that effective testing is the most effective way to both save lives and promote a timely return to a more normal society.”
The opening of the new laboratory at the Randox Science Park follows the company’s announcement that it is recruiting new staff across Science, Engineering and Manufacturing in support of its role within the national testing programme.
The 200 new positions will be involved in the testing of potential COVID-19 samples, as well as the construction of 200 new state-of-the-art diagnostic analysers which will significantly increase Randox’s capacity for COVID-19 testing.
Dr FitzGerald continued;
“Now that we have in place the infrastructure and laboratory space required to enhance our testing capacity, we look forward to implementing the next step in our COVID-19 investment programme.
“By accelerating the build schedule for new specialised equipment, and hiring 200 associated workers across Science, Engineering and Manufacturing we will further enhance the government’s national testing scheme, as well as facilitate testing more broadly across the general populace.”
Secretary of State Brandon Lewis MP welcomed the new investment saying:
“I was impressed during my visit with the dedication of staff and the top-class facilities at Randox. This investment will help support the UK’s nationwide effort to fight the coronavirus and ultimately save lives.”
Dr FitzGerald concluded;
“I would also like to take this opportunity to pay tribute to all my colleagues at Randox who continue to work assiduously to process such a high volume of tests in a timely manner.
“I know I speak on behalf of everyone when I say we appreciate all your hard work and the vital role you play in the practical application of COVID-19 testing.”
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A ground-breaking new test which improves the accuracy of stroke diagnosis has been developed by Randox scientists.
The rapid and highly sensitive blood test, which is due to be unveiled at this year’s Goodwood Festival of Speed, can uniquely differentiate between ischaemic strokes (a blood clot) and haemorrhagic strokes (a bleed) and subsequently enable clinicians to rapidly administer the most effective treatment, which is a vital factor in limiting permanent damage.
What’s even more remarkable is that the pioneering diagnostic, appearing as part of the festival’s Future Lab exhibition, takes less than 30 minutes to complete – making sure patients get the right diagnosis as fast as possible.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, whose team developed the test, commented;
“There is great tragedy in the fact that the majority of stroke damage can be minimised if intervention is delivered on time, yet too often the window closes before a diagnosis is made. For doctors, nothing is more frustrating.
“Excellent work has been undertaken to assist the public in recognising the signs of a stroke so people can get to hospital as quickly as possible. Our stroke test is the vital next step – assisting clinicians in making a rapid diagnosis and differentiation between haemorrhagic and ischaemic stroke, so their patients get the right treatment at the right time.”
Traditionally the first step in a stroke diagnosis is a CT scan, which, despite its ability to successfully diagnose haemorrhagic stroke, is significantly less capable of identifying ischaemic stroke.
Yet ischaemic stroke is the most common type of stroke and affects almost nine in ten patients. Its diagnosis and differentiation from haemorrhagic stroke is vital in enabling thrombolytic treatment to break down blood clots, which, given its nature, could be fatal if administered to a patient suffering from a haemorrhagic stroke. Worryingly though, in some areas of the UK, as little as 15% of eligible stroke patients receive this therapy in time.1
This is caused by a number of factors, including difficulty in determining stroke onset time, exceeding the appropriate time window for thrombolysis administration (4.5 hours from stroke onset), and importantly, not being able to differentiate ischaemic stroke from a number of other ‘stroke mimics’ including severe migraine, brain tumours, drug overdose and seizures.
The Randox Stroke Biochip successfully identifies ischaemic stroke in a rapid test which measures eight markers from a single blood sample simultaneously, in just 30 minutes.
John Lamont, R&D Director for Randox Laboratories, explained;
“While patients undergo a CT scan to confirm either the presence or lack of a haemorrhagic stroke, a blood test on the Randox Biochip can be run on our innovative point-of-care analyser, the MultiSTAT, to identify the same for an ischaemic stroke.
“For the almost 90% of stroke patients who are ruled out for haemorrhagic stroke2, the Randox Biochip will then accelerate decision making for clinicians with regards to thrombolytic therapy.
“Any treatment is most effective if started as soon as possible after the stroke occurs, and so every minute that passes without a diagnosis is likely to leave a permanent mark on a stroke patient’s future health and lifestyle. The vitally important diagnostic information from the Randox Stroke Biochip facilitates accurate stroke classification, directs the appropriate patient care pathway, and enables rapid thrombolytic therapy, ensuring a better patient outcome for ischaemic stroke sufferers, for whom time is of the essence.”
Whilst the Randox Stroke Biochip is currently being used as complementary testing in parallel with CT scanning, Mr Lamont is confident of a more prominent role for the test in the future patient pathway;
“The Biochip has the potential to really revolutionise the stroke diagnosis pathway as we currently know it. The accessibility of this type of blood testing could potentially extend its use beyond the A&E department, to ambulances and even the home, in the form of a hand-held testing device.”
For further information about our pioneering new stroke test, or about the Goodwood Festival of Speed Future Lab, please contact Amy McIlwaine in the Randox PR team by emailing firstname.lastname@example.org
1 Royal College of Physicians Sentinel Stroke National Audit Programme (SSNAP). Clinical audit Jan – Mar 2016 report prepared by Royal College of Physicians, Clinical Effectiveness and Evaluation Unit on behalf of the Intercollegiate Stroke Working Party.
2 Intercollegiate Stroke Working Party. National clinical guideline for stroke, 5th edition. London: Royal College of Physicians 2016.