In-Vitro Diagnostic (IVD) Tests for COVID-19
National Testing Strategy
The National Public Health Emergency Team (NPHET) is coordinating the management of and response to COVID-19 in Ireland. All testing for COVID-19 in Ireland is currently conducted in the National Virus Reference Laboratory (NVRL), in a number of hospital diagnostic laboratories and other designated laboratories. Samples are taken by healthcare professionals in healthcare settings, community test centres or in the patient’s home.
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.
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. Experts agree that serological assays currently cannot compete with molecular diagnosis, particularly in the early phase of infection. Any decision to change from the current testing strategy will be directed by the NPHET. Members of the public are advised to follow the HSE guidance in respect of testing. This is available on the HSE website.
Diagnostic testing for COVID-19 infection is critical to tracking the spread of the virus, understanding epidemiology, informing case management and reducing transmission. The Health Information and Quality Authority (HIQA) was asked to summarise the best available evidence regarding the diagnostic testing methods for the detection of to inform the work of the NPHET in their response to COVID-19. This report is available from the HIQA website.
In addition, a working document containing a literature review and initial guidance on performance criteria for COVID-19 tests, including RT-PCR tests, antigen and antibody tests, has been published on the European Commission’s website. This was developed by a project group comprising the Commission, the European Centre for Disease Control (ECDC) and representatives of experts from in vitro diagnostics competent authorities and health technology assessment bodies.
In due course the national testing strategy may change. Any future changes to the national testing strategy as directed by NPHET will also be communicated to healthcare professionals, members of the public and industry stakeholders.
Stakeholders (manufacturers, distributors) should contact the HPRA prior to supplying IVD test kits for COVID-19 to the Irish market. As this is a rapidly evolving situation, the HPRA can advise if a particular test is in line with the national strategy for COVID-19 testing in Ireland at a point in time. Documentation submitted should include:
EU Authorised Representative Details;
Manufacturer’s Declaration of Conformity;
Instructions for Use (IFU);
Images of the device labelling and packaging.
Queries can be submitted to our medical devices team at email@example.com.
Falsified Diagnostics Tests
The HPRA is aware of falsified tests for the diagnosis of COVID-19 circulating but has no evidence to date of their availability to members of the public in Ireland. Falsified tests are fake or counterfeit tests that vendors pass off as real and/or certified.
Current HPRA advice, in line with the NPHET strategy, is that members of the public should not purchase tests for COVID-19 online or from any other retailer. These tests may provide incorrect results.
Please see our Information Notice for further details.
Regulatory Derogation for Non CE-Marked Medical Devices for Covid-19
The HPRA has developed a Regulatory Derogations process specifically for the urgent assessment of applications to use non-CE marked medical devices and IVDs in Ireland, in the context of the Covid-19 emergency. The HPRA will assess these medical devices/IVDs to determine whether the provision of non-CE marked medical devices/IVD is in the interest of the protection of health and will work with the consultant and manufacturer applicants to complete the assessment as quickly as possible.
To apply for this derogation, please complete a manufacturer and a consultant application form and provide information regarding the medical device/IVD, its regulatory status and standards which have been applied. If you have any queries regarding this process, please contact firstname.lastname@example.org.