Dr. Cillian De Gascun:

I will speak about the testing component. Generally speaking, for any test that is provided a doctor has to have a pre-test suspicion. Certainly from the perspective of the National Virus Reference Laboratory, NVRL, our testing numbers date from the start of 2015 and we have performed over 21,000 tests for Lyme disease. That figure increased by approximately 50% between 2015 and 2017. We would infer that there is an increased awareness of Lyme disease and more testing for it. Despite the increased testing being performed, the number of positive test results has not increased significantly. In fact, it has probably decreased slightly which might suggest that more people who are not infected are being tested.

At the NVRL, we perform an enzyme-linked immunosorbent assay, ELISA, an antibody test that looks for immunoglobulin G, IgG. Generally speaking, as we heard earlier, in the early stages of infection with erythema migrans the sensitivity of that assay is low. That is well established and it is the reason we do not rely on it for the treatment of erythema migrans or early disease. However, we also know that in the late stage of the disease it is almost universally positive in patients who have had infection for more than, say, three to six months. The chances of patients presenting with a long-term illness of a year or two years or maybe more being falsely negative on the ELISA that we use are very slim.

We have referred approximately 1,200 of the 21,000 tests done since 2015 to the rare and imported pathogens laboratory in Public Health England in Porton Down, which is our reference laboratory. It engages in a two-stage process, performing a second enzyme immune assay and the western blot or the current equivalent, the immunoblot to which the Deputy alluded.

There is access to testing in Ireland. I operate a laboratory which receives more than 300,000 samples a year and we perform over 900,000 tests a year. If there were a better test available, I would want to perform it. I went into medicine to provide care for patients. We review our testing repertoire across all pathogens for which we test. We look for emerging pathogens and developments in the area in which we should be testing.

To touch on the previous point, there is no indication that there are better tests out there that we are not using. Our concern in the context of testing is that people are travelling overseas to use unaccredited tests which have not made it to market. Research to develop diagnostic testing for Lyme borreliosis has been taking place probably since the 1980s. The US Centers for Disease Control, CDC, made recommendations in the mid-1990s regarding the two-tiered approach and that has not been surpassed. If there were a better approach out there, pharma would be in like a shot. Equally, if there were better tests I would introduce them. The concern for us is that people are using tests that are not validated. I am not suggesting any testing approach is perfect, which is why we work with our clinical colleagues. If they have a high index of suspicion and my test is negative, we would refer it on and perform additional testing. There is no barrier to testing in our laboratory and I can certainly speak for the other laboratories around the country.