A "cohesive national testing strategy" is required to ensure Ireland is prepared to make the "best use" of emerging developments in testing for coronavirus, the health and safety watchdog has said.
The Health Information and Quality Authority (Hiqa) published a rapid health technology assessment of alternative diagnostic testing methods for detecting coronavirus, also known as Covid-19, at the request of the National Public Health Emergency Team (NPHET).
The assessment identified a wide range of diagnostic tests, both in development and already commercialised.
Hiqa found that the current test, the real-time reverse transcription polymerase chain reaction (real-time RT-PCR), remains the “gold standard” test for detecting and confirming coronavirus cases.
The assessment also found that newer RT-PCR kits have the potential to shorten turnaround times, alleviating pressure on the laboratories and facilitating faster clinical decision-making.
Ongoing review
However, Hiqa added that the other diagnostic tests will need to be independently clinically validated and verified, with ongoing review as part of a comprehensive quality assurance programme, before they can be adopted as part of a national testing strategy.
Dr Máirín Ryan, Hiqa’s deputy chief executive and director of health technology assessment, said the current test is the “most clinically-effective” test available.
"Efforts are currently under way to improve turnaround times for analysis, which will expand testing capacity and allow the labs to respond to the demand for increased testing," Dr Ryan said.
“Other tests under development, including rapid antigen tests and rapid antibody tests, must be proven to be safe and effective before they can be used in clinical decision-making to ensure that both physicians and patients have confidence in the test results.”
As Covid-19 is newly identified in humans, the adequacy and duration of immunity as well as the possibility of reinfection are largely unknown.
Hiqa said that this limits the usefulness of antibody tests in identifying individuals who may be immune to the virus.
Governance
“To this end, a cohesive national testing strategy is needed to ensure the right test is undertaken in the right person, at the right time and for the right purpose. This will enable appropriate governance of Covid-19 testing, including clear criteria for the administration and reporting of tests,” Dr Ryan said.
The assessment will inform NPHET’s decision-making to “ensure that Ireland is ready to move to new or improved testing methods when they become available”, Hiqa said.
The authority said it will continue to monitor and assess the evidence of emerging diagnostic tests available for Covid-19.
