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HPRA should be alerted on ‘home tests’

By Mindo - 26th Mar 2020

Healthcare professionals such as pharmacists and GPs who may be approached in relation to in vitro diagnostic (IVD) test kits for Covid-19 should contact the Health Products Regulatory Authority (HPRA), it has said.

The Authority said it can advise if the test is supported by the national testing strategy at a point in time. The HPRA can also advise if the test has regulatory approval for its intended purpose.

The current testing strategy in Ireland, based on expert advice, involves laboratory-based pathogen detection using nucleic acid technology (NAT) methods (PCR). 

“Members of the public should rely on their healthcare professional for guidance on testing for Covid-19…Please do not purchase tests for Covid-19 online or from any other retailer,” a HPRA spokesperson told the Medical Independent.

“Our experts agree that serological assays currently cannot compete with molecular diagnosis, particularly in the early phase of infection. This is particularly marked in those who are immunocompromised, and in the elderly.

“As such, tests conducted outside the existing agreed pathways are not currently in line with this strategy. Any decision to change from the current testing strategy will be directed by the NPHET [national public health emergency team].”

All testing for Covid-19 in Ireland is currently conducted in the National Virus Reference Laboratory (NVRL) and in a number of hospital diagnostic laboratories on samples taken by healthcare professionals.

“It is important to ensure that positive tests are reported to the relevant stakeholders (for monitoring and surveillance purposes) and contact tracing activities initiated (where appropriate),” stated the HPRA.

As such, tests conducted outside the existing agreed pathways are not currently in line with this strategy. 

“Stakeholders (manufacturers, distributors) should contact the HPRA prior to supplying IVD test kits for Covid-19 to the Irish market. As this is a rapidly evolving situation, the HPRA can advise if a particular test is in line with the national strategy for Covid-19 testing in Ireland at a point in time. Queries can be submitted to our medical devices team at,” stated the HPRA.

According to the European Centre for Disease Prevention and Control (ECDC), validation of performance and operational utility of selected rapid/point-of-care tests (eg, for antigen detection) is needed before recommending their use for clinical diagnosis.

Serological assays are currently not recommended for case detection.

“Sentinel syndromic and virological surveillance of ARI/ILI [acute respiratory infections/influenza-like illness] allows for the monitoring of community transmission and, together with surveillance of hospitalised cases, can help to define triggers for escalation/de-escalation of mitigation measures,” it has outlined.

Meanwhile, the ECDC said it is too early to know how long the protective immune response against SARS-CoV2 will last. This will require longitudinal serological studies that follow patients’ immunity over an extended period of time.

“Evidence from other coronavirus infections (SARS and MERS) indicates that immunity may last for up to three years and re-infection with the same strain of seasonal circulating coronavirus is highly unlikely in the same or following season.

“This could also hold true for SARS-CoV2 as there is emerging evidence from early studies suggesting that that individuals develop antibodies after infection and are likely to be immune from reinfection in the short term.

“Several commercial detection and serological assays for SARS-CoV-2 are on the market, however, information on their clinical performance is still limited. Validation of commercial assays is an urgent priority.”

Yesterday The Guardian reported that the UK government had purchased 3.5 million antibody tests that aim to determine whether a person has had the virus, and as such, is likely to have some immunity.

However, medical advisers to the UK government have said they need to be sure the tests work before they can be made available.

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