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Clostridioides difficile toxin A/B DNA

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Clostridioides difficile toxin A/B DNA

Clostridioides difficile (C.difficile) bacteria is found as part of the normal flora in the gut of approximately 1 in 30 healthy adults and in approximately 90% of infants. 

However, if the balance of bacteria in the gut is disturbed, such as following antibiotic treatment, the bacteria may multiply and produce toxins which can lead to illness. Symptoms range from mild diarrhoea to severe C.difficile colitis.

In 2020, more than 1700 laboratory confirmed cases of C.difficile infection were reported in Ireland. Outbreaks of C.difficile can occur in health and residential care settings. Prompt diagnosis of this infection allows for rapid treatment and implementation of infection prevention and control precautions. C.difficile is a notifiable disease.

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Clinical Details

‘C.difficile are capable of forming spores and are widespread in nature. Infection may be endogenous or from exogenous transmission via the faecal-oral route. Clinicians should suspect C.difficile infection in patients with diarrhoea in the presence of the following risk factors; recent or multiple antibiotic use, elderly, comorbidities, immunosuppression, recent gastrointestinal surgery, recent hospital stay or exposure to a person with CDI. Severe cases may lead to C.difficile colitis and urgent surgical assessment may be required.’

For the latest guidance on the diagnosis and management of C.difficile please refer to the HPSC guidelines, HSE Antibiotic Prescribing or The Infectious Disease Society of America (IDSA) guidelines:

Clostridioides difficile: Clinical guidance on diagnosis and management

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Sample Type &
Volume Required

Loose/liquid human faecal sample.

Enfer Medical

Tests/Assays

The test for Clostridioides difficile offered by Enfer Medical is carried out by real-time multiplexed PCR, as part of an extended gastrointestinal panel. The test is CE-IVD certified.

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Panel Tests
The pathogens detected on this panel are:
Bacteria Viruses Parasites
Campylobacter Adenovirus F40/41 Cryptosporidium
Clostridium difficile toxin A/B Astrovirus Cyclospora cayetanensis
Plesiomonas shigelloides Rotavirus  A Entamoeba histolytica
Salmonella Novovirus GI/GII Giardia lamblia
Vibrio  Sapovirus (Genogroups I, II, IV and V)
Yersinia enterocolitica
Escherichia coli/Shigella
Patient

Request Form

For clients using the Enfer Medical Client Portal, the Enfer Medical Patient Request Form (PRF) will be generated when you have completed your “Test Request” within the portal linked below.

Enfer Medical Portal

Please note that samples suspected of containing high risk pathogens such as Mycobacterium tuberculosis should be clearly identified on the form and packed separately from other samples.

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24 hours

Results are available next working day.

7 Days a Week

This assay is available seven days a week.

Packaging

The packaging/preparation of samples for delivery to the laboratory are required to be in adherence to all national regulations for the safe transport of biological materials. HSE guidance can be reviewed HERE.
There are specific packaging instructions and labelling requirements requiring triple packaging including:

  • Primary leak-proof container – tube or vial containing the sample.
  • Secondary watertight container, with absorbent material, intended to protect the primary container.
  • Outer container protects the secondary container.
  • Patient Request forms must be placed between the secondary container and the outer shipping container.


Further information on the packaging/preparation of samples for delivery to the laboratory is contained within the Enfer Medical Laboratory User Manual which clients are provided with.

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Storage & Stability

Samples must be tested within 4 hours of collection if stored at room temperature and samples must be tested within 4 days of collection if stored at 2-8°C.

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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 will be reported for each pathogen as:
Qualitative results
  • DETECTED
  • NOT DETECTED
  • INVALID
Please note this 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
Accessing

Your Results

Following receipt at the Laboratory, results should be available on the next working day and will be reported to the referring clinician via the Enfer Medical Client Portal or in a format agreed with clients.

Client Login

Established customers can login to the portal using the link above.

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