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.
Vivalytic
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
Mycoplasma genitalium
Treponema pallidum
Mycoplasma hominis
Ureaplasma urealyticum
Haemophilus ducreyi
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.
Enabling the management of multiple devices remotely, Vivasuite is the digital healthcare ecosystem allowing users to stay up to date with the latest tests and system updates.
Running within the Bosch IoT cloud maintaining the highest standard of IT security and data privacy. Connectivity ensures that devices are always available and fully updated.
SARS-CoV-2 Dual Target, Influenza A/B and RSV Rapid Test
Patients infected with SARS-CoV-2, Influenza A (Flu A), Influenza B (Flu B) and/or Respiratory Syncytial Virus (RSV) have overlapping symptoms, but the approaches to patient management of infections caused by the viruses are different. SARS-CoV-2, Flu A/B, and RSV is a qualitative test for the rapid triage, and patient management to identify different viruses effectively providing pathogen-specific management and targeted treatment.
The combination of these tests additionally reduces costs whilst addressing the challenge of respiratory infections at the point of care, facilitating infection control and risk assessment.
Detection Method: Real-Time PCR
Result Time: < 1 hour
Sample Volume: 300 μl
Sample Type: Nasopharyngeal or Oropharyngeal Swab
Detectable Pathogens
SARS-CoV-2 (E gene)
Influenza A and Influenza B
Human Respiratory Syncytial Virus
Vivalytic
Cartridge Based Testing Platform
The SARS-CoV-2 Dual Target, Influenza A/B and RSV 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.
Vivalytic Key Features:
Cartridge based platform
Fully automated
Suitable for both non-laboratory & laboratory settings
Small footprint device
Rapid turnaround from sample entry to results
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
“AWARD-WINNING DESIGN DELIVERS AN UNCOMPLICATED USER EXPERIENCE”
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 conditions2. 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 VivalyticMG, MH, UP/UU test detects and differentiates between pathogens of the Mycoplasmataceae family
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 our new MG, MH, UP/UU test, please contact market@randox.com
References:
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).
RT-PCR detection of common STI pathogenic bacterial species
Quick turnaround time of 1 hour, beneficial for both the patient and for the containment of STIs
Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings
Detection from a wide range of sample types including urine, urethral, vaginal, cervical and rectal swabs
Aiding in the diagnosis and containment of sexually transmitted infections (STIs) of symptomatic and asymptomatic individuals, the Vivalytic portfolio of tests has now expanded to complement current comprehensive screening.
The Mycoplasma genitalium (MG), Mycoplasma hominis (MH) & Ureaplasma parvum (UP)/urealyticum (UU) test guides appropriate treatment decisions at the earliest opportunity for improved patient management, prevention of transmission and supporting emerging macrolide resistance. MG, MH, UP/UU belong to the group of human pathogenic bacterial species associated with STIs even though particularly Ureaplasma ssp. are primarily considered as commensal organisms.
All four bacterial species can be detected simultaneously with the Vivalytic MG, MH, UP/UU test cartridge.
*Detail information on the determination of analytical performance can be found in instructions for use provided with the testing kit.
Detectable Bacteria
Mycoplasma genitalium
Mycoplasma hominis
Ureaplasma parvum/urealyticum
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
“AWARD-WINNING DESIGN DELIVERS AN UNCOMPLICATED USER EXPERIENCE”
Bacterial Differentiation to Promote Targeted Therapy
Improves patient pathways and the need for care with screening at both ward level, emergency settings and before elective surgery procedures identifying suspected sensitive or resistant bacterial staphylococcus strains.
Speed is key – 53 minutes for results vs 1-3 days for culture sampling
MRSA/SA screening contributes to current health risks by preventing contamination, breaking the chain of infection, and fighting against antimicrobial resistance and superbugs.
MRSA/SA is a qualitative RT-PCR test detecting and differentiating between methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive Staphylococcus aureus (MSSA) and methicillin-resistant coagulase-negative Staphylococci (MRCoNS). By using one single cartridge, the Vivalytic MRSA/SA test aids in the diagnosis of MRSA infection in a speedy manner so that appropriate antibiotic treatment can be applied, and complications prevented.
The Vivalytic has several key advantages over traditional culture methods.
Firstly, the Vivalytic point of care device can provide fast and accurate results, crucial when it comes to treating infectious diseases like MRSA.
Additionally, with closed-system testing the Vivalytic also offers reduced risk of contamination compared to traditional culture methods. This is because it uses closed-system testing, which minimises the chances of contamination and helps ensure the accuracy of the results.
Moreover, the Vivalytic system also offers reduced time to diagnosis at 53 minutes, which is vital for effective infection control and patient care in comparison to traditional methods which can take up to 2-3 days. With faster and more accurate results, healthcare professionals can quickly isolate and treat patients with MRSA, reducing the risk of spread and improving patient outcomes.
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
“AWARD-WINNING DESIGN DELIVERS AN UNCOMPLICATED USER EXPERIENCE”
Detection from real-time PCR via Nasopharyngeal and/Oropharyngeal swab or lollipop swab collection
The SARS-CoV-2 rapid test targets the E gene & N gene sequence for COVID-19 detection
The SARS-CoV-2 rapid test has recently received CE marking
Simple and easy to use analyser with a small footprint making it suitable for use in laboratory and non-laboratory settings
Rapid turnaround time of just 30 – 49 minutes from sample entry to result*
Convenient 4 step process from sample entry to results. No laboratory training required
SARS-CoV-2 dual target is a rapid real time PCR test cartridge, providing clear and concise results in a timely manner, direct at the point of care. This enables the patient to take the recommended safety precautions without delay.
The SARS-CoV-2 dual target rapid test allows for detection of both the E-gene and N-gene sequence for SARS-CoV-2 with minimal workflow required, suitable for laboratory and non-laboratory settings. The SARS-CoV-2 dual target test also contains a Human and Internal PCR control for convenience.
In collaboration with Bosch, we are proud to release not only a rapid testing solution for the detection of SARS-CoV-2 but an accelerated mass testing solution to effectively and efficiently monitor and detect viral infection from the offset with an aim of minimising the rise in infections globally. The new SARS-CoV-2 pooling test will allow users to test up to 160 samples a day and has sensitivity of 98% and a specificity of 100% – a world’s first!*
*Detail information on the determination of analytical performance can be found in instructions for use provided with SARS-CoV-2 kit.
*Test Termination: If one of the target genes is clearly detected, the test can be terminated prematurely with the valid positive result.
Vivalytic Workflow
Detectable Virus
SARS-CoV-2 (E-gene and N-gene sequence)
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
“AWARD-WINNING DESIGN DELIVERS AN UNCOMPLICATED USER EXPERIENCE”
Rapid PCR MRSA/SA testing now available on Vivalytic
Providing a quick diagnosis of methicillin resistant at the point of the care, the latest addition to the Vivalytic portfolio of tests, not only provides rapid RT-PCR results in 53 minutes but differentiates whether the bacterial strain is methicillin-resistant (MRSA) or methicillin-sensitive (MSAA) which promotes targeted therapy.
MRSA is a major multi-resistant nosocomial pathogen worldwide with the WHO estimating that the mortality rate of patient infection rates is around 50% higher compared with patients who have been infected by non-resistant Staphylococcus aureus strains.1 Moreover, the extensive period of hospitalisation, morbidity, and the associated medical costs increase significantly with an MRSA infection.2
Introducing MRSA to the vivalytic portfolio can provide high quality answers, anywhere and anytime improving patient pathways and the need for care. Significantly, introducing rapid MRSA screening at both ward level, emergency settings and before hospital elective surgery procedures allow for an effective response to identifying whether the bacteria strain is methicillin-sensitive (MSSA) or -resistant.
Making a point to care, the rapid essence and speed of Vivalytic not only showcase technology but the ability to contribute to current health risks by preventing contamination, breaking the chain of infection, and again fighting the silent pandemic of antimicrobial resistance (AMR) & superbugs.
The treatment on the front line today looks at increasing empirical antibiotic prescribing and increasing drug-resistant outbreaks. AMR is growing rapidly, with superbugs threatening the ability to treat common infectious diseases appropriately. The COVID-19 pandemic has elevated concerns over AMR and antibiotic-associated adverse events, with surges in antibiotic prescribing, hospitalisations, and drug-resistant bacterial transmissions.
Speed is key here – since the result of diagnostics with culture sampling, which is the current traditional method for MRSA testing is only available after one to three days, this PCR test for the point of care is ideal as an additional tool when speed is of the essence.
Few points to note about the current Vivalytic panel for MRSA/SA detection:
By using one single cartridge, the Vivalytic MRSA/SA test detects and differentiates between MRSA and MSSA DNA to aid in the diagnosis of MRSA infection in a speedy manner so that appropriate antibiotic treatment can be applied, and complications prevented.
Making this happen, The MRSA/SA 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.
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.