Additional reporting by Vivienne Clarke
A member of the National Public Health Emergency Team (Nphet) has expressed concern about the accuracy of antigen tests set to be sold at petrol stations.
MyBio, a Kilkenny-based life sciences company, has launched the 15-minute antigen tests, which claim to be European Union-certified and have a 97.83 per cent accuracy rate.
They will be available in Circle K and Applegreen filling stations across the country from tomorrow.
MyBio is happy to explain to Colm how to calculate the accuracy of the test
On Friday morning, HSE chief clinical officer and Nphet member Dr Colm Henry told Newstalk Breakfast that while he did not know the details and had not seen the test, the accuracy figures did not “sound right” to him.
In response, managing director of MyBio Linda Nolan described Dr Henry’s comments as “disappointing”.
“Dr Colm Henry is not in a position to challenge the accuracy of the test because these tests have been validated independently and certified in Europe,” Ms Nolan said.
“It has been put through a certification process where the testing has been verified by a notified body the TUV in Germany.
“These tests have been compared with the gold standard PCR tests and the calculation of sensitivity, specificity and accuracy have been made on that basis.
"It is really surprising and disappointing that the HSE's chief clinical officer Dr Henry has assumed that this is not the case. MyBio is happy to explain to Colm how to calculate the accuracy of the test.”
MyBio said the European-manufactured tests, made in partnership with German company MP Biomedicals, are CE certified. This signifies that a product sold in the European Economic Area (EEA) has been “assessed to meet high safety, health, and environmental protection requirements”.
Speaking on Newstalk Breakfast, Dr Henry questioned the accuracy of the test, which has not been validated by the HSE.
“We look at the sensitivity of the test based on how readily it picks up a test on self-testing compared to our gold-standard PCR test. Let's not forget the purpose of the tests we have - it's a public health test," he said.
“It's in the best interests that we pick up truly infectious cases - not just people who are symptomatic, people who are pre-symptomatic or people who are asymptomatic carrying the virus. And the PCR test is by far the most effective test for that purpose.”
Dr Henry said he would be concerned that somebody who should get a PCR test if they are symptomatic or think they may have the virus would rely on the antigen test and behave accordingly. They should “do the right thing” and get a more sensitive PCR test, he said.
Antigen testing had a role as part of the overall Covid response, he said, “but like anything else, you don't pick it out and displace everything else and say 'just because I've an antigen test everything else is fine, and it absolves me from anything else I have to do in relation to Covid-19'.”
In Circle K, the tests will be priced at €8 for an individual test, with two tests for €14 and three tests for €20.
Circle K has said the tests are "not intended as the sole basis to diagnose or exclude a Covid-19 case".
Gordon Lawlor, managing director of Circle K Ireland said: “As society continues to reopen and with strong progress on the vaccine rollout front, we feel there is a demand for access to antigen testing products to help further manage the risk associated with this virus.
“We see the use of antigen tests as a complementary additional safety measure alongside the existing public health advice and Government guidance.
“It is really important that customers continue to abide by these measures and exercise good judgement when it comes to the usage of antigen tests.”