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Genital Ulcer - Syphilis

The majority of genital ulcers are caused by sexually transmitted infections (STIs).

The most common cause of genital ulcer disease (GUD) is herpes simplex virus, followed by infection with the bacterium Treponema pallidum which causes syphilis.  Distinguishing the cause of GUD is challenging without accurate diagnostic tests.

The genital ulcer assay used at Enfer Medical is a CE IVD multiplex real-time PCR for detection of Herpes Simplex Virus type 1 (HSV-1) DNA, Herpes Simplex Virus type 2 (HSV-2) DNA, Treponema pallidum (TP) DNA, and Varicella-zoster virus (VZV) DNA from genital swabs. Diagnosis of the specific pathogen(s) associated with GUD allows appropriate therapeutic choices and decreases the risk of transmission to others.

Clinical Details

There are several stages of syphilis infection: early infection which is divided into primary infection, secondary infection, and early latent infection and late syphilis which includes latent, cardiovascular and gummatous syphilis. The average incubation period is 21 days but can range from 10-90 days. Early infectious syphilis (EIS) relates to the following clinical stages; primary, secondary and early latent. The Health Protection Surveillance Centre was notified of 611 cases of EIS on Ireland during 2020.

Primary syphilis: The classic lesion of primary syphilis is a single, painless and indurated ulcer with a clean base. This is called a chancre. However, there is significant variability in morphological presentation and can therefore be unreliable.

Secondary syphilis: There may not be a sharp demarcation between primary and secondary stage syphilis. The chancre may also still be present. Secondary syphilis is often a subtle disease as skin lesions may be easily overlooked or mistaken for other dermatologic diseases.

Latent (early & late) syphilis: The latent or asymptomatic stage of syphilis is defined as the disappearance of the secondary manifestations until therapeutic cure or tertiary manifestations develop. This stage is arbitrarily divided into early and late latent syphilis based on the spontaneous infectious relapse of untreated patients. Approximately 90% of relapses occur within 1 year, these cases are known as early latent syphilis. 94% of relapses occur within 2 years and the rest occur over 4 years. Relapses occurring after 1 year are defined as late latent syphilis.

Tertiary syphilis: This stage presents at the end stage of infection, 10-30 years after initial infection. Tertiary syphilis has many different clinical presentations. i) Cardiovascular syphilis, ii) Neurosyphilis and iii) Late benign disease. Tertiary syphilis can occur 10-30 years after initial infection.

The diagnosis of Syphilis depends on clinical findings, examination of lesion materials and/or serologic tests for syphilis. As it is not uncommon to have more than one concurrent STI infection presenting as GUD clinical diagnosis is challenging. More recently monkeypox virus infection has added to the challenge as disease presents with similar genital lesions.

Case Study
At Enfer Medical, we have integrated a cutting-edge and fully automated WASPLab® (Walk Away Specimen Processor) that has significantly enhanced our testing capabilities to ensure the highest of quality when processing patient samples.
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WASPLab® at Enfer Medical
Our entire microbiology workflow has been optimized using automation and highly sophisticated robots to ensure uninterrupted incubation for rapid bacterial growth and improved turnaround times for patients.
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Our Services

Service
Health & Wellness
General health and wellness testing can include a variety of tests, depending on the needs of the individual or recommendations of
Find Out More
Service
Sexual Health
Regular STI screening facilitates early treatment and reduces the long-term consequences of infection.
Find Out More
Service
Respiratory Health
Rapid early pathogen identification has important treatment and infection control implications. See our range of tests here.
Find Out More
Service
Reproductive & Female Health
Hormonal analysis is hugely beneficial to identifying problems that can arise during the reproductive years.
Find Out More
Service
All Services
View the full suite of services at Enfer Medical here.......
Find Out More
Sample Type &
Volume Required

Genital swab specimen in 1-3 mL viral transport media (VTM):

  • ENAT PM 2ML REGULAR APPLICATOR (Copan)
  • UTM with Flocked Swabs (Copan)
  • Swab Speciman Collection Kit (Qiagen Corporation)

Please note for patients with suspected Monkeypox infection, samples should be collected in viral inactivation buffer. The eNAT specimen collection and transport device has been validated for this purpose and can be supplied by our team at Enfer Medical or sourced through local distributors.

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Panel Tests
The pathogens detected on this panel are:
Viruses  Bacteria
Herpes Simplex Virus 1 Treponema pallidum
Herpes Simplex Virus 2
Varicella Zoster Virus
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Transporting
Samples

In addition to the packaging of samples, the transport/delivery of clinical samples to the laboratory is required to be in adherence to all national regulations for the safe transport of biological materials. Enfer Medical provides a fully compliant logistics service, aligned with clients’ testing requirements.

Prompt transport of specimens:
To ensure prompt testing of samples and release of results within the published test turnaround times, samples should arrive to the laboratory by 18:00. Test turnaround time is measured from receipt of the sample at the laboratory until the time the authorised results are reported to users.

Acceptance/Rejection
of Samples

In rare cases specimens may not be suitable for testing on arrival to the laboratory. In that case the sample will be rejected at the receipt stage and the service user will be notified immediately and an explanation as to why the sample could not be processed will be provided. Reasons why samples cannot be processed include but are not limited to:

  • Samples received beyond the stability limits and/or not at the correct temperature indicated for each test.
  • Incorrect sample type received.
  • Leaking samples, sample not received or sample insufficient for analysis as stated below within sample requirements.
  • Non-compliant samples or request forms i.e. those missing sample date information, missing sample test request and/or missing sample site/type information.
  • Samples received without the necessary patient identifiers.
Clients will be provided with guidance on Sample Receipt Anomalies.

Our Services

Service
Health & Wellness
General health and wellness testing can include a variety of tests, depending on the needs of the individual or recommendations of
Find Out More
Service
Sexual Health
Regular STI screening facilitates early treatment and reduces the long-term consequences of infection.
Find Out More
Service
Respiratory Health
Rapid early pathogen identification has important treatment and infection control implications. See our range of tests here.
Find Out More
Service
Reproductive & Female Health
Hormonal analysis is hugely beneficial to identifying problems that can arise during the reproductive years.
Find Out More
Service
All Services
View the full suite of services at Enfer Medical here.......
Find Out More
Result Values:
Qualitative results for each Pathogen on the Panel will be reported as:
Qualitative results
  • DETECTED
  • NOT DETECTED
  • INVALID
Please note that Syphilis is a notifiable disease under the Infectious Diseases (Amendment) Regulations 2020 (S.I. No. 53 of 2020) February 2020.

Please refer to the Health Protection Surveillance Centre for the Case Definitions for Notifiable Diseases:

HPSC Link
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Our Services

Service
Health & Wellness
General health and wellness testing can include a variety of tests, depending on the needs of the individual or recommendations of
Find Out More
Service
Sexual Health
Regular STI screening facilitates early treatment and reduces the long-term consequences of infection.
Find Out More
Service
Respiratory Health
Rapid early pathogen identification has important treatment and infection control implications. See our range of tests here.
Find Out More
Service
Reproductive & Female Health
Hormonal analysis is hugely beneficial to identifying problems that can arise during the reproductive years.
Find Out More
Service
All Services
View the full suite of services at Enfer Medical here.......
Find Out More