HIQA publishes a rapid health technology assessment on COVID-19 diagnostic testing

Date of publication:

The Health Information and Quality Authority (HIQA) has published a rapid health technology assessment (HTA) of alternative diagnostic testing methods for detecting COVID-19, as requested by the National Public Health Emergency Team (NPHET).

Dr Máirín Ryan, HIQA’s Deputy CEO and Director of Health Technology Assessment, said: “The World Health Organization (WHO) has identified that testing for COVID-19 is critical to tracking the viral spread, understanding the epidemiology of the disease, informing case management and reducing transmission. To ensure that Ireland is ready to make the best use of emerging developments in this area, we assessed the available evidence for the alternative diagnostic tests, whether any of these tests are being used internationally, and when the tests could be deployed in the clinical pathway.”

The assessment identified a wide range of diagnostic tests, both in development and already commercialised. However, before these tests can be adopted as part of a national testing strategy, they will need to be independently clinically validated, locally verified, with ongoing review as part of a comprehensive quality assurance programme. The current test, real-time RT-PCR*, remains the ‘gold standard’ test for detecting and confirming COVID-19 cases.

Dr Ryan continued: “Real-time RT-PCR is the most clinically-effective test available. Efforts are currently underway to improve turnaround times for analysis, which will expand testing capacity and allow the labs to respond to the demand for increased testing. 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.

“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.

“This 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 will continue to monitor and assess the evidence on alternative diagnostic testing approaches for COVID-19 as it emerges and will participate in a European joint rapid HTA on testing.  

The Rapid HTA of alternative diagnostic testing approaches for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is available from the link below.

Further information:
Marty Whelan, Head of Communications & Stakeholder Engagement
085 8055202, mwhelan@hiqa.ie

Notes to Editor:

  • *The current test being used in Ireland is the real-time reverse transcription polymerase chain reaction (real-time RT-PCR).
  • The assessment identified two types of diagnostic tests for SARS-CoV-2: those that detect the virus or virus particles such as RT-PCR and antigen testing; and those that detect the body’s immune response to the infection such as antibody testing. Both testing approaches are clinically relevant at different time points during the clinical course of infection.
  • Newer RT-PCR kits have the potential to shorten turnaround times alleviating pressure on the laboratories and facilitating faster clinical decision-making.
  • In principle, antigen testing is faster than RT-PCR and, subject to the availability of a reliable validated test, could be used to triage patients for SARS-CoV-2 and reduce the need for molecular (RT-PCR testing). However, it is generally less sensitive than RT-PCR, so any negative test may need confirmation with RT-PCR.
  • At a population level, validated antibody tests could be used in seroprevalence studies to assess the proportion of the population that has been exposed to SARS-CoV-2. This information will be useful to inform implementation or easing of public health measures.
  • As SARS-CoV-2 virus is newly identified in humans, the adequacy and duration of immunity as well as the possibility of reinfection are largely unknown. This limits the usefulness of antibody tests in identifying individuals who may be immune to SARS-CoV-2 (e.g. “immunity passports”).
  • HIQA’s Deputy CEO and Director of Health Technology Assessment, Dr Máirín Ryan, is chair of the NPHET subgroup on Guidance and Evidence Synthesis.
  • HIQA’s COVID-19 public health guidance database can be accessed at this link. The database is used to inform the ongoing response to COVID-19, specifically the development of public health guidance to protect the public.
  • Read HIQA’s research, reviews and evidence summaries to inform the national response to COVID-19 at this link.
  • HIQA continues to support the national public health response to COVID-19 through:
    • conducting rapid HTAs, rapid reviews and evidence summaries to inform decisions by NPHET and NPHET subgroups, including its clinical Expert Advisory Group; and to inform public health measures and public health guidance to protect the public from COVID-19,
    • assessing nursing homes as part of a quality assurance programme,
    • providing guidance and support to designated centres,
    • risk assessing nursing homes and designated centres for people with a disability,
    • evaluating risk in public acute hospitals,
    • establishing an Infection Prevention and Control Hub to provide advice and assistance to social care services,
    • carrying out contact tracing,
    • prioritising the registration of additional beds in the social care system.