In-Vitro Diagnostic (IVD) Tests for COVID-19

Updated: 22 December 2020

The regulation of COVID-19 diagnostic tests

The tests used for COVID-19 are classified as in-vitro diagnostic medical devices (IVDs) that is, they analyse a sample in-vitro (outside the body) for the presence of either the virus (e.g. RNA or antigen) or the body’s immune response to the virus.

Currently tests for COVID-19 are regulated under the European In-Vitro Diagnostics Directive (IVDD, Directive 98/79/EC) and must be CE-marked and used as outlined in the accompanying product literature called instructions for use (IFU).

The HPRA’s involvement in the national response to COVID-19

The HPRA, as the national competent authority for the regulation of medical devices and IVDs, is a member of the National Public Health Emergency Team (NPHET) and other groups including the HIQA Expert Advisory Group on COVID-19 and supports the national testing strategy.

In the context of the national testing strategy the HPRA contributed to HIQA Health technology assessments published in October 2020 titled Rapid HTA of alternative tests to detect current infection with SARS-CoV-2 and in May 2020 titled Rapid HTA of alternative diagnostic testing for coronavirus 2 (SARS-CoV-2).

More information about COVID-19 testing is available below. Please click the titles below to expand each section. 

 

National Testing Strategy

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. 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 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, for those that meet the case definition (people with symptoms) or their identified close contacts, 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.

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).

The HPRA has not prohibited the sale or purchase of legitimately CE-marked COVID-19 test kits on the market in Ireland, but is highlighting the importance of understanding the limitations of certain test kits.

Limitations of certain test kits

The HPRA continues to highlight known concerns with COVID-19 tests provided by commercial entities outside of the national testing strategy. The HPRA cautions members of the public that meet the case definition (people with symptoms) or are an identified close contact, not to undertake tests from commercial entities for the following reasons:

  1. Test results may not be accurate

    • If the incorrect sample type is used. For example, a finger-prick sample may be appropriate for some tests and not for others. Using the wrong sample type could lead to inaccurate test results.

    • If the process involves ‘self-swabbing’ as it can be difficult to assure a valid sample has been obtained.

  2. Antibody tests are not suitable to diagnose a current infection, results may be misinterpreted

    • As this is a new virus, not a lot is known in relation to immunity and COVID-19 and the limitations of antibody testing need to be understood and carefully communicated.

    • Due to the uncertainty regarding the interpretation of antibody results, these tests are not currently recommended for widespread use.

  3. An incorrect or misinterpreted result may give rise to an individual failing to isolate, or seek the necessary medical help. During this time, the individual may unknowingly spread the virus or their illness might progress.

  4. Test results may not be reported centrally for monitoring, surveillance and contact tracing purposes.

Types of COVID-19 tests

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, such as proteins(antigens)]. These tests are generally performed in laboratories.

Indirect tests
(serology tests) i.e. tests that will detect the immune response (Antibody test) to the virus 

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.

Laboratory-based real-time reverse transcription polymerase chain reaction (rRT-PCR) to detect viral RNA is the current gold standard diagnostic test. Antigen detection tests can be laboratory-based (such as ELISA) or intended for use in near-patient settings (such as rapid antigen detection tests [RADTs]). To date RADTs are generally less sensitive than rRT-PCR.

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.

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.

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