The Health Information and Quality Authority (HIQA) has published a rapid health technology assessment (HTA) on alternative tests to detect SARS-CoV-2, the virus that causes COVID-19. 

At present, rRT-PCR is the reference standard for diagnosis of current infection with SARS-CoV-2 in Ireland. The National Public Health Emergency Team (NPHET) requested that HIQA carry out a rapid health technology assessment of alternative tests and approaches to rRT-PCR.

Based on the scientific literature, international recommendations, and input from the COVID-19 Expert Advisory Group, HIQA has advised NPHET that it is not possible to provide an across-the-board endorsement of specific technologies due to variation in performance of individual tests.

Dr Máirín Ryan, HIQA’s Director of Health Technology Assessment and Deputy Chief Executive, said: “The evidence shows that effective testing strategies rely on a portfolio of tests, using different technologies that can be applied in different settings and situations. There is no single test that is suited to all contexts.

“While testing people at or near the point of care, including with the use of rapid antigen detection tests, has the potential to expand test capacity, reduce test turnaround times and improve access, such tests typically show reduced diagnostic accuracy compared with the current test. Therefore, depending on the circumstances, results from a rapid antigen detection test may need to be confirmed with the current rRT-PCR test.”

HIQA also advised that the introduction of validated rapid testing in Ireland should now be considered to enhance COVID-19 prevention and control, while efficient processes with accurate and reliable rapid tests would facilitate timely clinical management and public health measures.

Dr Ryan continued: “Clinical validation studies help determine the real world performance of tests. Before any new test is implemented, it is crucial that these studies are undertaken in Ireland in the settings for which use of the test is planned. Adopting alternative approaches to laboratory-based testing needs to involve consideration of clinical performance (sensitivity and specificity), disease prevalence, turnaround time and ease of use, all of which will inform the selection of the most appropriate test for each setting.

“The introduction of testing at or near the point of care must be within the context of a supporting quality management system. Along with the adoption of accurate and reliable rapid tests, such a system would support the quality assurance, governance, training and reporting requirements essential to ensure the ongoing safety, validity and reliability of the testing service.

“A cohesive national strategy is needed to ensure the right tests are undertaken in the right people at the right time for the right purpose. Planning now to support delivery of the strategy will facilitate rapid deployment of tests that meet the requisite standards once validated for use.”

The findings and advice were submitted to NPHET for their consideration and to inform public health advice on 7 October 2020.  

Read the Rapid health technology assessment (HTA) of alternatives to laboratory-based real-time RT-PCR to diagnose current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at www.hiqa.ie. 

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Further information:

Marty Whelan, Head of Communications & Stakeholder Engagement
01 814 7480/085 805 5202, mwhelan@hiqa.ie 

Notes to Editor:

• This rapid health technology assessment described the range of tests which could be used to detect SARS-CoV-2. It examined the diagnostic accuracy of new and emerging tests, identified testing approaches used internationally, and explored operational considerations in adopting alternative testing methods in Ireland. 
• In interpreting test findings, a negative result should be interpreted as ‘SARS-CoV-2 not detected’ rather than ‘not infected with SARS-CoV-2’. Conversely, positive results do not exclude concomitant bacterial infection or co-infection with other viruses. 
• Rapid antigen detection tests (RADTs) are simpler than molecular tests such as rRT-PCR from an equipment point of view, potentially allowing detection of SARS-CoV-2 at the point of care. They also produce results faster than tests used in the laboratory setting. However, such tests typically have reduced diagnostic accuracy compared with laboratory-based rRT-PCR and therefore are not suitable for all settings of testing. 
• HIQA’s advice to NPHET is informed by research evidence developed by HIQA’s COVID-19 Evidence Synthesis Team, with expert input from HIQA’s COVID-19 Expert Advisory Group. 
• HIQA’s COVID-19 Evidence Synthesis Team produces a variety of outputs including rapid health technology assessments, scoping reports, rapid reviews of public health guidance, and evidence summaries, supplemented by an evidence-to-advice framework to guide the development of advice, where appropriate.
• HIQA’s COVID-19 Expert Advisory Group is a multidisciplinary group, comprising nominated representatives from the relevant clinical specialties and areas of expertise, methodology experts, and public representation.