‘Align Covid-19 testing regime with Europe’

Government urged to consider rapid antigen Covid-19 testing in line with latest European recommendation

The Government is being urged to align its Covid-19 testing regime with European Commission (EC) guidance adopted yesterday (November 18) on how to select rapid antigen testing systems, when they are appropriate and who should perform them.

“Obviously, the RT-PCR testing should be used where possible. However, due to the time taken to get a result using PCR testing, there may be benefit in looking for a testing system that delivers quicker results especially in emergency or in point-of-care scenarios,” maintained Ireland South Member of the European Parliament (MEP), Billy Kelleher.

He added there were clearly many scenarios where a rapid, antigen test could be used. For example, where a quick test result in a rapidly escalating setting was needed, an antigen test may be preferable to a reverse transcriptase-polymerase chain reaction (RT-PCR) test. The Commission suggested that this might be the case in the health sector or in nursing homes.

“Using rapid, antigen testing, in conjunction with RT-PCR testing, could be useful in containing the spread of the virus, detecting infections and limiting isolation and quarantine measures,” he said.

The Commission recommendation supported the use of rapid antigen tests as offering the potential for rapid identification of those individuals at greatest risk of spreading the infection, particularly in circumstances of high community transmission.

In particular, the latest recommendation focused 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 recommendation also called for validation and mutual recognition of tests and their results. This comes ahead of the European Leaders’ virtual meeting today (Thursday, November 19) on the European Union response to the Covd-19 pandemic.

The EC recommendation outlined, as stressed by the World Health Organization (WHO), while the rapid antigen tests may offer helpful solutions for the diagnosis of severe acute respiratory syndrome coronavirus 2 infection in a range of settings and scenarios, their clinical performance was not yet optimal and caution should be exercised.

Among existing models, the WHO recommended the use of rapid antigen tests that met minimum performance requirements of greater than 80 per cent sensitivity and greater than 97 per cent specificity, and that these tests should be used in particular when the availability of RT-PCR tests was temporarily limited or where prolonged turnaround times precluded clinical utility.

Regarding the possibility to use of antigen tests in asymptomatic persons, the Commission added that, until now, “very limited” data was available regarding the performance of rapid antigen tests in this context. Moreover, for the currently available rapid antigen tests, manufacturers’ instructions did not mention asymptomatic persons as a target population.


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