In-Vitro Diagnostic (IVD) Tests for COVID-19
Updated: 28 August 2020
HPRA advice on IVD testing for COVID-19
The HPRA has cautioned members of the public not to undertake any COVID-19 tests provided by commercial entities outside of the national testing strategy. The known risks associated with these tests have been highlighted in our information notices.
While stakeholders (manufacturers, distributors, commercial entities) are asked not to supply IVD tests for COVID-19 to the Irish market that are not in line with the national testing strategy, the HPRA has not prohibited the sale or purchase of legitimately CE-marked COVID-19 tests on the market in Ireland.
In due course, the national testing strategy may change. Any future changes to the national testing strategy as directed by NPHET will be communicated to healthcare professionals, members of the public and industry stakeholders.
Laboratories, pharmacies and any other stakeholders are welcome to contact us directly with any queries (firstname.lastname@example.org).
National Testing Strategy
In Ireland, the National Testing Strategy for COVID-19 involves testing people who meet the case definition (people with symptoms) or their identified close contacts. It is directed by the National Public Health Emergency Team (NPHET) and coordinated by the HSE. Samples are taken by healthcare professionals in healthcare settings, community test centres or in the patient’s home.
The current testing strategy in Ireland, based on expert advice, involves laboratory-based pathogen detection using nucleic acid technology (NAT) methods. Specifically, this involves the use of polymerase chain reaction (PCR) techniques. Polymerase Chain Reaction/PCR works by generating many copies of the specific SARS‐CoV‐2 genetic material to levels that are measurable.
Experts agree that serological assays currently cannot compete with molecular diagnosis (such as PCR), particularly in the early phase of infection. All testing for COVID-19 as part of the national strategy is currently conducted in the National Virus Reference Laboratory (NVRL), in a number of hospital diagnostic laboratories and other designated laboratories.
These tests are provided free of charge and there is currently sufficient capacity in the system for testing through this pathway. Members of the public are advised to follow the HSE guidance in respect of testing. This is available on the HSE website.
A national testing strategy has been implemented to ensure that;
test results are reported to the relevant stakeholders (for monitoring and surveillance purposes as COVID-19 is a notifiable disease);
contact tracing activities are initiated (where appropriate);
an incorrect test result does not lead to false reassurance resulting in individuals failing to seek the necessary medical help. During this time, the individual may also unknowingly spread the virus.
More information about COVID-19 testing is available below. Please click the titles below to expand each section.