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Dáil Éireann díospóireacht -
Wednesday, 24 May 2000

Vol. 519 No. 6

Priority Questions. - Blood Transfusion Service.

Alan Shatter

Ceist:

16 Mr. Shatter asked the Minister for Health and Children the reason platelets are currently tested under the old serological process for hepatitis C; the further reason a PCR test is not used; if his attention has been drawn to the fact that the serological test does not detect hepatitis C in someone infected 14 weeks before donation; and if, as a consequence of the failure to conduct such testing, patients are being placed at risk. [14199/00]

Since November 1999, all blood donations collected by the Irish Blood Transfusion Service are screened by PCR for hepatitis C. PCR testing is a further safeguard aimed at improving the detection of hepatitis C during the window period. The typical length of the window period without PCR testing is ten to 14 weeks. Following the introduction of PCR testing, this window period is reduced to, on average, 25 days. In order to introduce this test as rapidly as possible, the IBTS contracted with the Scottish National Blood Transfusion Service, SNBTS, in Edinburgh to conduct the test on its behalf. The SNBTS was selected as it has an aggressive programme for the introduction of PCR testing for all donations. The transfusion service in Northern Ireland has also contracted with the SNBTS for PCR.

The use of PCR results as a release criteria for blood components by the IBTS is being introduced in parallel with the SNBTS. At present, the majority of PCR test results are returned to the IBTS on the fourth day after the donation has been taken. The test format being used in Scotland requires two to three working days in the laboratory after donation. A small number of samples require further analysis because of difficulties associated with this test. The test results are currently faxed to the IBTS. Electronic exchange of data when the IBTS's new computer system is implemented in the summer will improve turnaround time in the transmission of results. In the case of platelets, which have a shelf life of five days, improvement in assay and turnaround times will be required before PCR test results can be used to determine release of these products.

Approximately 160,000 donations are tested annually by the IBTS. Donations found positive in serological tests are discarded and not issued. No such reactive result by PCR has been observed to date. In the unlikely event that a PCR positive result is observed, for example, a window period donation, appropriate follow up, including product recall, will be initiated. The risk of transmission of hepatitis C in the window period is currently estimated as one in 500,000 as current mandatory tests are extremely robust and sensitive. The Irish Medicines Board, which is the regulatory authority, is satisfied with the current position regarding the implementation of PCR testing by the IBTS. It is not a mandatory test for blood components in Europe or in the United States.

Additional Information.Blood components transfused in Irish hospitals meet all European standards. Over and above these standards, the IBTS plans to enable all components, including platelets, to be tested for PCR as a release criteria before the end of this year. This will coincide with similar arrangements in Scotland and in Northern Ireland and will be an advance on the majority of other European transfusion centres. The IBTS plans to perform PCR testing at its new headquarters within the next 12 months when a testing system is validated and fully operational.

Does the Minister agree platelets account for up to one in three transfusions? Does he also agree the present serological testing does not detect hepatitis C in a person infected 14 weeks before donation, and I refer specifically to platelets?

Does the Minister accept that, in the absence of PCR testing being used for platelets, there is a genuine and serious risk of hepatitis C infection? Does he also accept it is a clear that to provide a safe product, the current arrangements with Scotland are grossly inadequate in regard to the use of platelets?

The current arrangements are the best available. It is worth pointing out that within the European Union, Holland, Germany and Austria are the only EU countries which have, to date, successfully introduced PCR testing. It is the intention of the IBTS to enable all components, including platelets, to be tested for PCR as a release criteria before the end of this year. That is the target it has set. As I said, there is a risk of one in 500,000 in terms of the window period and the aim and objective of the IBTS is to have, by the end of the year, all components tested for PCR and to have the most up to date and state of the art facilities, including PCR testing capacity.

The European Committee for Proprietary Medicinal Products requires that all manufactured blood products for use in the European Union be derived from plasma pools tested negative for hepatitis C by a validated PCR test. Does the Minister acknowledge that we do not comply with that at present? Does he agree failure to address this issue with the necessary speed creates a genuine risk that some patients may contract hepatitis C? Does he acknowledge that the language he used in his reply, that is, that we are doing the best we can at present, is a mirror image of the type of approach adopted previously which resulted in hundreds of men and women – primarily women, but men in certain circumstances – contracting hepatitis C from contaminated blood products?

I reject the Deputy's comments about the language I used. Obviously, we are taking this issue very seriously as is the IBTS. More importantly, the Irish Medicines Board, which is the regulatory authority, has expressed satisfaction with the current position. The IBTS is anxious to make sure it has the wherewithal to ensure all components, including platelets, will be tested for PCR as a release criteria before the end of the year. In fairness, one has to look at what has been happening on an international scale. We, and the IBTS, in particular, are working to have the state of the art facilities here to remove all risk.

The professor of medicine in Cork is greatly concerned about the window period.

I read the article which gave rise to the question and I am not convinced in terms of the facilities being available in this country. The article suggested that facilities already exist in this country that would ensure the quicker turnaround. I am not satisfied that is the case, and I have been advised it is not the case.

We need the facilities.

Yes. I have no difficulty with the fact we need the facilities.

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