Enfer Medical uses Altona RealStar and Euroimmun EURORealtime SARS-CoV-2 RNA RT-PCR assays to test for the presence of SARS-CoV-2 viral RNA in nasopharyngeal and oropharyngeal swabs. These are both CE IVD approved test kits. The Altona assay has two targets, the lineage β- βCov and the E gene, whereas the Euroimmun assay targets ORF1ab and the N gene. Turn-around time for this test is 24 hours.
Enfer Medical
Tests/Assays
Sample Type &
Volume Required
Enfer Medical WGS Test:
Our Whole Genome Sequence service is carried out using COVIDSeq tests sourced from Illumina Ireland Commercial Limited.
A swab (flocked swab of man-made material) stored in Primestore MTM with an RT-PCR positive SARS-CoV-2 RNA, with a Ct value <25* and which have more than 0.6ml residual volume available for processing. *Samples with a Ct value >25 can be processed by special request
Patient
Request Form
The Enfer Medical Patient Request Form can be downloaded. It is important that Patient Request Forms are correctly and fully labelled, to include a minimum of two unique identifiers.
It is important that Patient Request Forms are correctly and fully labelled, to include at least two unique patient identifiers.
72-hours
from the time of receipt at the Laboratory.
72 hours
72-hours from the time of receipt at the Laboratory for samples meeting the selection criteria. The WGS laboratory is run seven days a week.
Storage
Swabs should be transported to the laboratory without delay. If a sample collection device using a lysis buffer is used, then the swabs may be stored at room temperature for up to 7 days. From 7-days post collection, swabs should be stored at -20C. The quality of the sample is a major determinant in identifying the causative agent.
Packaging
Service users posting or transporting samples by air, sea, rail and road must adhere to all national regulations for the safe transport of biological materials. Compliance is mandatory to reduce risk to couriers, carriers, laboratory staff and passengers. Enfer Medical Ltd does not accept samples suspected of containing Category A infectious substances. Infectious Category B (UN3373) samples can be transported by specialised couriers or through the postal service, provided they comply with the required packaging instruction. 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. Patient Request forms should not be placed inside the secondary container.
Transporting
Samples
Samples
Prompt transport of specimens: It is the responsibility of the sender to comply with courier, postal or international safety regulations for the safe transport of clinical specimens. Please consult the relevant guidance at the Health and Safety Authority.
To ensure prompt testing of samples and release of results within the published test turnaround times, samples should arrive to the laboratory by 15:00. The use of a courier service is recommended, especially for URGENT samples. 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
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 are rejected 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.
- Grossly 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 a Guidance Document for 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
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Service
Sexual Health
Regular STI screening facilitates early treatment and reduces the long-term consequences of infection.
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Service
Respiratory Health
Rapid early pathogen identification has important treatment and infection control implications. See our range of tests here.
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Service
Reproductive & Female Health
Hormonal analysis is hugely beneficial to identifying problems that can arise during the reproductive years.
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