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.
Introducing MG, MH, UP/UU Testing to Vivalytic
Aiding the rapid diagnosis of sexually transmitted infections (STIs) and immediate decision making at the point of care, the Vivalytic portfolio of tests has now expanded to complement current comprehensive screening for STI’s, introducing rapid screening for Mycoplasma genitalium (MG), Mycoplasma hominis (MH) & Ureaplasma parvum (UP)/urealyticum (UU) in 1 hour.
What are MG, MH, UP/UU pathogens?
According to the World Health Organization (WHO), over 30 different bacterial species, viruses and parasites have been identified to be involved in the spread of STIs. Mycoplasmas in particular belong to the group of human pathogenic bacterial species with many risk associations particularly on the female reproductive system.1 Studies have also found that UU and MH are implicated in prematurity-linked conditions 2. UP & UU bacterium again are implicated to have adverse implications for both men & women. They affect up to 70% of sexually active couples and exist mostly in an asymptomatic state. If left untreated, UP & UU may be associated with infertility and other risk associations such as meningitis and pneumonia. 3
Why test MG, MH, UP/UU on Vivalytic?
Current diagnostic cultivation methods for screening can take up to three days for MH, UP and UU or even 6 months, with the introduction of these STI pathogens to the Vivalytic, quick, accurate diagnosis and immediate treatment decisions can be made at the point of care , before symptoms worsen, or any long-term implications occurs to the patient. In a world where over 1 million STIs are acquired daily 5, a quick and efficient process that allows for almost immediate results can improve operations considerably.
The push to encourage individuals to test themselves regularly before engaging in sexual activities with a new partner is becoming more and more widespread. The Vivalytic, as a portable point of care device, designed to suit a range of environments such as Doctors’ offices or GUM/ Sexual Health Clinic, can provide a screening immediately, minimising the stress and uncertainty a patient may experience whilst waiting for a result to receive the relevant treatments if needed. The Vivalytic’s speed not only provides reliable and precise diagnoses, but also plays a role in fighting the spread of STIs and minimising hospitalisations that may arise from complications from undetected sexually transmitted pathogens.
Features and Benefits
- By using a single cartridge, the Vivalytic MG, MH, UP/UU test detects and differentiates between pathogens of the Mycoplasmataceae family
- Detection Method: Real-Time PCR
- Result Time: 1 hour
- Sample Volume: 300μl Clinical Sample
- Sample Type: Swab (Urethral, Vaginal, Cervical, Rectal), Urine
What makes this possible?
Making this happen, The MG, MH, UP/UU rapid test on Vivalytic by Bosch, a point of care platform brought to the market by Randox Laboratories. The Vivalytic system is a fully automated, cartridge-based platform capable of both Hi-Plex and Lo-Plex infectious disease testing. Each easy-to-use cartridge contains all necessary reagents, is fully sealed to minimise risk and can be conveniently stored at room temperature.
Making a point to care, the Vivalytic also provides a comprehensive sexual health profile of 10 bacterial, viral, and protozoan infections with a rapid turnaround time of just 2 hours from sample entry to result. Designed to offer a complete sexual health profile with an aim of prevention and control, the Vivalytic STI array can be used to diagnose existing infections whilst any identifying co-infections.
The Vivalytic consolidates the full molecular workflow into a small benchtop platform, capable of extraction, PCR amplification and detection. It follows an easy 4 step process from sample entry to results and with the gold standard PCR testing. With most up to date technology, the Vivalytic has wireless connectivity, with no peripherals required, making a unique space saving and hygienic solution. Handling and utilisation are simple and medical professionals require only minimal training.
For more information on the Vivalytic, why not visit our webpage: https://www.randox.com/vivalytic-molecular-point-of-care/
For more information on our new MG, MH, UP/UU test, please contact email@example.com
- Mardh P. A., Westrom L., von Mecklenburg C., Hammar E. Studies on ciliated epithelia of the human genital tract. I. Swelling of the cilia of Fallopian tube epithelium in organ cultures infected with Mycoplasma hominis. The British Journal of Venereal Diseases. 1976;52(1):52–57.
- Viscardi R. M. Ureaplasmaspecies: role in neonatal morbidities and outcomes. Archives of Disease in Childhood: Fetal and Neonatal Edition. 2014;99(1):F87–F92.
- World Health Organization. “Sexually Transmitted Infections (STIs).” int, World Health Organization: WHO, 22 Nov. 2021, www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis).
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- UK-based diagnostics firm supporting call for responsible use of antibiotics in conjunction with European and International Antibiotics Awareness initiatives
- New molecular diagnostic multiplex assays hold the key to first-time, accurate diagnosis of infectious diseases
- Assays have the power to diagnose primary, secondary and asymptomatic co-infections to inform appropriate antibiotic prescribing
UK-based diagnostics company, Randox Laboratories, is supporting the call for patients and prescribers to ‘resist and desist’ antibiotic use in the fight against antimicrobial resistance this European Antibiotics Awareness Day. Coinciding with international awareness weeks in Australia, Canada and the USA, the concerted efforts of health authorities around the world to curb the spread of antimicrobial resistance is testimony to the global reach of the issue.
Now declared a ‘major threat’ by the World Health Organisation, Randox has been working at the forefront of this global challenge to deliver effective diagnostic solutions to arm against this growing problem. Developed over two decades of research and an investment of £200m, Randox’s innovative Biochip Array Technology (BAT) is the latest weapon in the fight against antimicrobial resistance, with the ability to simultaneously detect multiple pathogens in a single test for rapid and accurate diagnosis.
Randox’s range of molecular assays within infectious disease enable the detection of primary, secondary and asymptomatic co-infections for a more comprehensive understanding of the drivers of infection in individual patients. The Randox STI Multiplex Array simultaneously detects up to 10 pathogens from a single patient sample, whilst the Randox Respiratory Multiplex Array rapidly screens for 22 bacterial and viral upper and lower respiratory tract infections, with same day result reporting, for rapid diagnosis.
As Randox Managing Director Dr Peter FitzGerald CBE FREng explains, screening for all potential pathogens in infectious disease is vital in ensuring accurate diagnoses can be made; “Even after a confirmed diagnosis, many patients who haven’t been tested for a wider range of pathogens may harbour co-infections, impeding the effectiveness of therapeutic treatment and prolonging exposure to infection.
“Through a more comprehensive screening strategy at initial presentation, a complete patient profile can be obtained which will give clinicians greater understanding of the working of the disease and allow them to diagnose and prescribe correctly, ruling in or out the need for antibiotics, and helping to control their appropriate use.”
Antibiotic resistance has largely been fuelled by patient and prescriber overreliance on using antibiotics to treat disease. Once considered to be ‘magic bullets’ for curing infections, antibiotics are now firing blanks as they become ineffective against many common and treatable infectious diseases, such as the sexually transmitted infection, Neisseria gonorrhoeae, and respiratory tract infections such as staphylococcus aureus and streptococcus pneumoniae, which have been shown to be acquiring increasing levels of resistance to antibiotic treatment.
“First-time, accurate diagnosis of infection through molecular testing is key to treating infections correctly. The availability of these assays provides a powerful weapon in the fight against antimicrobial resistance and we would encourage health providers around the world to utilise this technology to help curb the spread of the problem.”
For more information visit Randox: www.randox.com.