John McGuinness (Carlow-Kilkenny, Fianna Fail)
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496. To ask the Minister for Health the reason the results of tests for Lyme disease carried out by a laboratory (details supplied) are not accepted by the Health Service Executive; if the same standard of test can be undertaken here; if so, the location in which; if tests undertaken here are restricted in any way; and if he will make a statement on the matter. [17584/17]

Simon Harris (Wicklow, Fine Gael)
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Lyme disease (also known as Lyme borreliosis) is an infection caused by a spiral-shaped bacterium called Borrelia burgdorferi.It is transmitted to humans by bites from ticks infected with the bacteria. The infection is generally mild affecting only the skin but can occasionally be more severe and highly debilitating. Lyme disease is the commonest cause of tick-borne infection in Europe.

In general, it is accepted clinical practice in Ireland, the UK, Europe and North America that laboratory confirmation is unnecessary for a confidently-made, clinical diagnosis of erythema migrans (the initial primary skin lesion of Lyme borreliosis). However, this only affects about ¾ of patients. For later presentation Lyme borreliosis, the two-tier system is necessary to ensure that false-positive diagnosis (i.e. the test incorrectly indicates a patient has Lyme disease when, in fact, they do not have the disease) are kept to a minimum. Serological testing for antibodies to Borrelia burgdorferi is the mainstay of diagnostic testing.

There have been significant improvements in antibody testing in recent years, making diagnosis more certain than in the past. Testing for Lyme borreliosis is currently undertaken in most of the larger hospitals in Ireland. The standard approach to Lyme diagnostics is a two-stage process and involves using a sensitive enzyme immunoassay (EIA – a test to detect proteins found in the Borrelia bacterium) as an initial, screening step. Screening EIAs can be insufficiently specific, giving false-positive reactions (i.e. leading to over diagnosis) in the presence of other infections such as syphilis, and certain, common viral infections including glandular fever. In addition, false-positive results can also occur in patients with autoimmune disorders and other inflammatory conditions including, rheumatoid arthritis, scleroderma, diabetes or ulcerative colitis. Samples giving reactive or equivocal results in Initial screening tests are further investigated in a second-stage, confirmatory immunoblot (such as Western blot) test. Use of immunoblot testing greatly increases specificity (i.e. it reduces the likelihood of these false positive results). Using this two stage approach gives a considerably greater degree of certainty around the diagnosis of Lyme. All clinical (and other) laboratories in Ireland, must undergo continuous quality assurance to ensure that the quality of the laboratory tests they provide is maintained at conform to the highest internationally-accepted standards of microbiological excellence.

As testing for Lyme borreliosis is widely available in Ireland there is no requirement for people to travel to other EU Member States to access this service. This question refers to a facility in Germany and it would be inappropriate for me to comment on individual health facilities in another EU Member State.