I propose to take Questions Nos. 899 to 902, inclusive, and 904 to 906, inclusive, together.
On 18 November 2020, the European Commission adopted a recommendation on the use of rapid antigen tests for the diagnosis of COVID-19. It sets out guidance where Member States might conduct rapid antigen tests in addition to RT-PCR tests in clearly defined settings where the deployment of antigen tests is appropriate, and with the aim to contain the spread of the coronavirus, to detect SARS-CoV-2 infections and to limit isolation and quarantine measures.
The Recommendation focuses on criteria to be used for the selection of rapid antigen tests, the settings during which rapid antigen tests are appropriate to be used, test operators, and validation and mutual recognition of rapid antigen tests and their results. The use of rapid antigen tests can be recommended to test individuals, regardless of symptoms, in settings where the proportion of test positivity is expected to be 10%, e.g. in the context of contact tracing and outbreak investigations.
HIQA recently completed a report into Rapid Antigen Detection Testing. The HIQA report found that antigen tests to date show reduced diagnostic accuracy compared with rRT-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 rRT-PCR is unavailable, or where prolonged turnaround times preclude clinical utility.
As a result of the HIQA report, the National Public Health Emergency Team asked the HSE to investigate the possible deployment of antigen tests in Ireland. The HSE has established an Antigen Project Validation Working Group whose aim is to validate the antigen tests in the market and evaluate the public health deployment options, including evaluation of the potential uses in various settings.
The objectives of the group include assessing the international evidence on the use of antigen testing, defining sensitivity and specificity levels for appropriate antigen testing, identify specific tests that will form part of the validation process, validation of antigen tests across a range of settings including symptomatic and asymptomatic persons, develop public health guidelines on the appropriate use of antigen testing, and consideration of the operational implications of deploying antigen testing in Ireland.
The HSE has recently issued a tender for procurement of antigen tests and Ireland is also participating in an arrangement for the supply of antigen tests through the Joint Procurement Agreements at EU level.
The RNA PCR test remains the gold standard test for diagnosing Covid-19 cases, consistent with international best practice and continues to be fundamental to identifying the source and containing the spread of the virus in Ireland.