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 (devices@hpra.ie).

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.

Types of COVID-19 tests

Currently IVD tests for Covid-19 are regulated under the IVDD (Directive 98/79/EC) and must be CE-marked in accordance with their intended use.

There are two types of tests for COVID-19:

Test type

Sample

What is the test used for?

Direct detection of the virus

Throat/Nose swab

These tests are used to diagnose a current infection by testing for the virus itself [either the genetic material (PCR test) or other parts of the virus]. These tests are generally performed in laboratories.

Antibody tests to detect evidence of recent or past infection

Blood

(finger-prick or collected from vein)

These tests can indicate a past or recent infection. These tests aim to detect if your immune system has produced antibodies, which bind to and may fight the virus. Some antibody tests are very low technology (lateral flow) tests and others are carried out in a laboratory.

The first group contains tests that can detect the presence of the virus itself (RNA and antigen tests). The main purpose of these tests is to support the diagnosis of patients with COVID-19-like symptoms, to screen for infections in crucial target groups such as healthcare workers, and to test whether an individual recovered from COVID-19 is still infectious.

The second group of tests detect the immune response of the body i.e. they report on past or recent infection with the virus (antibody tests). The level of protective immunity conferred by antibodies is still under investigation. Scientific evidence to date has found that (serology based) antibody tests are not optimal to diagnose a current infection; they may be beneficial to determine a recent or past exposure to the virus. Also due to lack of development tools and regulatory standards such as international reference standards, common technical specifications and availability of adequate serology samples (including seroconversion panels) the performance of some tests evaluated to date has been poor.

Of note, further to the publication of the HIQA HTA report, a NPHET subgroup on Diagnostic Testing approaches was established and this group has issued a Strategic Framework Document. It includes the following recommendation (#8) to restrict lateral flow antibody tests to research only:

‘NPHET has noted and accepts the recommendation from the WHO that the use of point-of-care (POC)/near patient lateral flow immunoassays (LFIA) or immunochromatographic antibody tests (ICT) is currently not recommended in any setting other than for research. Evidence supporting their use for specific indications is required before any further recommendation can be made. In the interim, use of these tests may undermine the public health response to COVID-19.’

Due to the uncertainty regarding the interpretation of antibody results, these tests are not currently recommended for widespread use. And, in light of the NPHET recommendation, the HPRA does not support the use of lateral flow antibody tests for any clinical decision making.

Falsified diagnostic tests for COVID-19

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 2020(02) for further details.

Links to useful publications

Source

Description/link

European Commission Regulatory Guidance on IVDs for COVID-19

A number of publications are available on the European Commission website providing information on a range of topics relating to IVD tests for COVID-19.

HPRA Information Notices 

National/European Publications