Sexually Transmitted Infections – Rapid Testing at the Point of Care

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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


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