IRELAND WILL RECEIVE its first allocation of antigen tests from the European Commission in the first quarter of this year, according to the HSE. 

Before Christmas, the European Commission signed a contract with Abbott and Roche allowing the purchase of over 20 million rapid antigen tests at a cost of €100 million. 

It is recommended that EU countries use antigen tests in certain situations and settings, such as diagnoses among symptomatic cases, contacts of confirmed cases, outbreak clusters, screening in high-risk areas and closed settings.

The Commission also recommends using rapid antigen tests for population-wide screening in epidemiological situations or areas where the proportion of test positivity is very high.

Previously, it recommended that in order to mitigate the impact of Covid-19 in healthcare and social-care settings, rapid antigen tests – which can deliver results in about an hour – should be considered at admission to healthcare facilities, as well as for triage of symptomatic patients or residents.

It said in high prevalence situations or where PCR testing capacity is limited, rapid antigen tests should be considered for recurring testing (every 2-3 days) of staff of health-care, home and social care, other long-term care facilities, closed settings, such as prisons, detention centres, and other reception infrastructures for asylum seekers
and migrants.

First quarter 2021

When asked about Ireland’s roll out of antigen testing, the HSE told TheJournal.ie that “Ireland will receive its first allocation of these antigen tests in the first quarter of 2021″.

It also confirmed that a “proposal for their use in symptomatic patients within defined contexts has been made and decisions regarding deployment are currently in train”.

Over the last year, there have been discussions about what role antigen testing can play in the country’s testing regime. Currently, the only validated test recognised in Ireland is the PCR test. After someone is swabbed, the PCR test has to be sent to a lab for analysis. 

HIQA was asked by the National Public Health Emergency Team (NPHET) to undertake an expedited health technology assessment of the alternatives to the PCR test.

In a statement, the HSE said HIQA considered a wide range of alternative tests and testing strategies, investigated the extent that alternatives to the PCR are currently in use or recommended for use internationally, while also summarising the diagnostic accuracy of available alternatives. 

Potential organisational considerations and resource implications that might arise from the use of alternative tests, including antigen testing, to support PCR testing was also considered.

The HIQA report found that antigen tests to date show reduced diagnostic accuracy as compared to the PCR.

“In addition many of the early tests in the market offer poor diagnostic accuracy. Due to reduced sensitivity, the WHO suggests that these rapid tests should only be used when PCR testing is unavailable, or where prolonged turnaround times preclude clinical utility,” said the HSE.

It noted that the antigen test sensitivity is significantly lower than PCR testing and can vary significantly across brands, noting that there is limited performance data currently available for the use of antigen tests in asymptomatic populations.

“The ECDC and WHO recommend that any country considering implementing antigen testing should conduct appropriate clinical validation of the tests for use in that setting.

“As a result the HSE has established a Working Group who are verifying and validating a range of tests available in the marketplace, together with the options and impacts arising from the deployment of those tests,” said the HSE.

Nearing completion 

The working group assessing rapid antigen tests is currently underway in Ireland and is nearing completion, it is understood.

In rolling out antigen testing for member states, the European Commission says that governments should clarify whether a PCR test might be needed to confirm a positive antigen test, or a second rapid antigen test is required for confirmation.

A common list of rapid antigen tests will be drawn up by the Commission to ensure that member states recognise tests from other countries.