Vol. 520 No. 1
221 Mr. Allen asked the Minister for Health and Children if he will make a statement on recent reports (details supplied) that thousands of patients are receiving blood components that did not undergo the most rigorous test available for hepatitis C. [15156/00]
Since November 1999 all blood donations collected by the Irish Blood Transfusion Service, IBTS, 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. 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 criterion for blood components by the IBTS is being introduced in parallel with the SNBTS. 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 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 the United States.
