Dr. Cillian De Gascun:

First, I do not want to give the impression that there has not been engagement with the DAA in regard to its demands. The HSE has been heavily involved in trying to identify what that future might look like whereby travel becomes safe again.

In the context of validation, in essence, what we do is to take the gold standard, which at the moment is PCR, and then go into a setting, wherever that setting may be. For the new test that we want to verify or validate, which might be antigen testing, LAMP testing or a different PCR assay, we would take two samples from a population. One sample goes through the gold standard test, which we know is PCR, and the other sample goes through the comparator test, whether that is an antigen, LAMP or otherwise. We would need significant numbers. In essence, what we are doing with that comparison is trying to identify the sensitivity and specificity and the real-world performance of the new test.

We know PCR works very well. The HSE and the Department of Health have put a huge amount of infrastructure in place over the last eight months to ensure we can now do somewhere in the region of 120,000 tests a week. That system is working well. If we are going to change it or add something new to it, we need to make sure that whatever that is continues to work as effectively, and we need to make sure that all of those data feed into our test and trace system.

The last point to highlight is that testing is just one component. An Australian virologist has put out a very nice graphic around the Swiss cheese model of pandemic defence against respiratory virus. Every slice has holes in it, so testing has holes in it and tracing has holes in it, but if we have the physical distancing, the contact tracing, the hand hygiene, the face masks and all of those things, and we put all of those slices together, then we can get through this.

From the validation perspective, there is a logistics component to it and it is not as straightforward as just buying a kit off the shelf and then going out to a local community and validating it. We need to identify the cohort we want to test it in, and we need to know what the numbers are going to be and how many negatives or positives we want.

Equally, who is going to do the swabbing? We have worked with the HSE to identify community sampling hubs within the community, where we can look at the likes of saliva and antigen testing. From an NVRL perspective, we are not best placed to do antigen testing because antigen testing is typically near-patient; it is done at the point of care. There are hospitals involved in doing the antigen comparison between PCR and antigen testing. One of the other elements that is difficult is that the same specimen that goes through the antigen testing cannot go through PCR, so multiple samples are required. All of those things-----