Sexually Transmitted Infections – Rapid Testing at the Point of Care

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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.
Global Burden

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

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.

2017-08-02-BHCS_Vivalytic-Anwendung-0616-CMYK-Edited

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 PanelMG, MH, UP, UU Panel
Chlamydia trachomatisMycoplasma genitalium
Neisseria gonorrhoeaeMycoplasma hominis
Trichomonas vaginalisUreaplasma 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.
Vivalytic Reflection

For more information please contact us at: marketing@randox.com


Welcome to Vivasuite!

Vivasuite | The Digital Ecosystem for Vivalytic

Connectivity at the Point of care

 

 

Welcome to Vivasuite!

 

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.

Register your interest

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.

 

 

Advantages of Vivasuite:

 

– Schedule remote software updates

– Know when your devices were last synchronised

– View all devices in one dashboard

– View device information and general device data

View testing history from one system

– Mobile device monitoring

– Vivalytic user management

– Save time with less “on-device” work

Vivalytic Overview

Discover more about the Vivalytic

 

 


Vivalytic | SARS-CoV-2 Dual Target, Flu A/B and RSV

Vivalytic | SARS-CoV-2 Dual Target, Influenza A/B and RSV Rapid Test

 

Rapid differentiation between SARS-CoV-2, Flu A/B, and RSV

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”

Download Vivalytic Brochure

Want to know more?

Contact us or visit our COVID-19 Monitoring & Management page

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Vivalytic Resource Hub

Vivalytic | Resource Hub

Making a Point to Care

 

  • Brochures
  • Flyers
  • Videos
  • Scientific Papers

Vivalytic

VIVALYTIC MG, MH UP/UU Educational Guide

VIVALYTIC MRSA/SA Educational Guide

Vivalytic Overview

Discover more about the Vivalytic

 

 

SARS-CoV-2 Dual Target, Flu A/B and RSV

SARS-CoV-2 Dual Target

Viral Respiratory Infection Array

Sexually Transmitted Infection Array

SARS-CoV-2 Pooling Test

MG, MH, UP/UU Rapid Test

SARS-CoV-2 Rapid Test

MRSA & MSSA Rapid Test

Randox Vivalytic

Vivalytic Installation & Operator User Guide

Vivalytic: Instructional Promo Video

Vivalytic: COVID-19 Testing Process

Coronavirus Testing on the Vivalytic POC Analyser

EVALUATION OF A MULTIPLEX REAL-TIME PCR ASSAY FOR THE DIAGNOSIS OF SEXUALLY-TRANSMITTED INFECTIONS

RAPID AND ACCURATE DETECTION OF MYCOPLASMATACEAE IN CLINICAL SAMPLES


Rapid MG, MH, UP/UU Testing Now Available on Vivalytic

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
DETECTABLE PATHOGENS
  • Mycoplasma genitalium (MG)
  • Mycoplasma hominis (MH)
  • Ureaplasma parvum (UP)/urealyticum (UU)

 

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 market@randox.com

References:

  1. 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 hominisThe British Journal of Venereal Diseases1976;52(1):52–57.
  2. Viscardi R. M. Ureaplasmaspecies: role in neonatal morbidities and outcomes. Archives of Disease in Childhood: Fetal and Neonatal Edition2014;99(1):F87–F92.
  3. 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).

Want to know more about Randox?

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Vivalytic Cartridges Hub


Vivalytic | MG, MH, UP/UU Rapid Test

Vivalytic | MG, MH, UP/UU Rapid Test

 

Detection of Mycoplasma genitalium, Mycoplasma hominis & Ureaplasma parvum/ urealyticum

RT-PCR detection of common STI pathogenic bacterial species

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    Quick turnaround time of 1 hour, beneficial for both the patient and for the containment of STIs
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    Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings
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    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”

Download Vivalytic Brochure

Want to know more?

Contact us or visit our COVID-19 Monitoring & Management page

Related Products

Viral Respiratory Infection Array

SARS-CoV-2 Pooling Test

Vivalytic

Vivalytic Test Menu


Vivalytic | MRSA & MSSA Rapid Test

Vivalytic | MRSA/MSSA Rapid Test

Rapid differentiation between MRSA & MSSA in 53 minutes

Bacterial Differentiation to Promote Targeted Therapy

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    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.
  • Early Error Detection
    Speed is key – 53 minutes for results vs 1-3 days for culture sampling
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    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.

Detectable Pathogens Specific Gene Targets
Methicillin-resistant Staphylococcus aureus (MRSA) SCCmec/orfX junction, mecA/ mecC, SA422
Methicillin-sensitive Staphylococcus aureus (MSSA)

Vivalytic vs traditional culture methods

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”

 

Download Vivalytic Brochure

Want to know more?

Contact us or visit our COVID-19 Monitoring & Management page

Related Products

Viral Respiratory Infection Array

SARS-CoV-2 Pooling Test

Vivalytic

Vivalytic Test Menu


Vivalytic | SARS-CoV-2 Rapid Dual Target

Vivalytic | SARS-CoV-2 Dual Target Rapid Test

Detecting E & N gene sequence for SARS-CoV-2

SARS-CoV-2 Dual Target Detection

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    Detection from real-time PCR via Nasopharyngeal and/Oropharyngeal swab or lollipop swab collection
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    The SARS-CoV-2 rapid test targets the E gene & N gene sequence for COVID-19 detection
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    The SARS-CoV-2 rapid test has recently received CE marking
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    Simple and easy to use analyser with a small footprint making it suitable for use in laboratory and non-laboratory settings
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    Rapid turnaround time of just 30 – 49 minutes from sample entry to result*
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    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”

Download Vivalytic Brochure

Want to know more?

Contact us or visit our COVID-19 Monitoring & Management page

Related Products

Viral Respiratory Infection Array