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Mycobacterium Tuberculosis (IGRA)

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Mycobacterium Tuberculosis (IGRA)

Mycobacterium tuberculosis causes tuberculosis (TB). TB primarily affects the lungs and is associated with significant morbidity and mortality, particularly in high-risk or endemic areas.

Important priorities for control and eventual elimination of TB include rapid identification and treatment of individuals with active TB and laboratory diagnosis and treatment of individuals with latent TB infection (LTBI). LTBI screening should be considered for healthcare workers, those newly arriving in Ireland and individuals commencing immunosuppressive therapy.

Currently, two types of tests for the diagnosis of latent TB infections are used: tuberculin skin tests (TSTs) and Interferon-γ release assays (IGRAs). The QuantiFERON-TB Gold is one such IGRA assay which is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluation.

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Clinical Details

Most TB infections are initiated by the respiratory route of exposure.

Clinical manifestations of pulmonary TB infection typically include cough, night sweats and weight loss. Extrapulmonary lesions can appear in some individuals. Infection may be divided into stages which include primary TB, latent infection and reactivation.

Infection can remain latent in a proportion of cases. Latent tuberculosis infection carriers are asymptomatic and not infectious, however, about 10% will go on to develop active TB. Reactivation of infection is more common in immunocompromised patients.

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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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Sample Type &
Volume Required

5mL venous lithium heparin plasma.

Enfer Medical

Tests/Assays

The test for Mycobacterium tuberculosis offered by Enfer Medical is carried out using the QuantiFERON TB Gold Plus assay. This test is CE-IVD certified.

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Patient

Request Form

For clients using the Enfer Medical Customer 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 - 48 hours

Results are available within 24 -48 hours

5 Days a Week

This assay is available five days a week (Monday – Friday)

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.


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. 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

Specimens must be tested within 2 days of collection and 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 as:
Quantitative 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 Case Definitions for Notifiable Diseases
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 Customer Portal or in a format agreed with clients.

Customer Login

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

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