Written Answers - Hepatitis C Testing.
Trevor Sargent
Question:
265
Mr. Sargent
asked the
Minister for Health and Children
the guarantee, if any, he can give if a person is diagnosed negative for hepatitis C, that this diagnosis will hold for a lifetime; and whether it can unexpectedly change as seems to be the case for over 500 people mentioned in the media, owing to a bad batch of Anti-D in the mid-1970s.
[14373/97]
In his question, the Deputy refers to approximately 500 people whose diagnosis for hepatitis C has unexpectedly changed. This is not the case.
Under the Blood Transfusion Service Board's screening programmes for hepatitis C, approximately 75,000 people have come forward for testing. In the latter part of 1996, the BTSB became aware that, in spite of their intensive efforts, not everyone who had been exposed to potentially infectious doses of anti-D in 1977-78 had come forward for testing. Persons who had not come forward were identified following a cross-check of the lists of people tested under the programmes against available anti-D record cards from 1977-78. Through this process, the BTSB identified over 500 women who, earlier this year, were invited, either directly or through their general practitioners, to consider coming forward for testing as they had received anti-D from potentially infectious batches. This is the group of approximately 500 which was recently mentioned in the media.
In addressing the Deputy's question in relation to a negative diagnosis for hepatitis C, this is clearly a medical issue. However, I understand that the protocols for hepatitis C testing are as follows:
Initial tests are performed by the Virus Reference Laboratory (VRL) at UCD or by the Blood Transfusion Service Board. Both organisations currently use the third generation ELISA test. This is a highly sensitive test which is specifically designed to detect the viral type identified in the infected anti-D immunoglobulin produced in 1977, as well as to detect past exposure to the virus.
Where an ELISA test is positive, a confirmatory RIBA test is performed by the VRL. Where the RIBA test is positive, or indeterminate, a further confirmatory test called PCR is performed by the VRL. This test detects the presence of current infectivity.
Both the VRL and the BTSB utilise the most up-to-date and reliable diagnostic tests available. In all cases, the person's general practitioner is notified of the results of all the tests performed, and expert scientific support is available at the VRL and at the BTSB to advise on the significance of the results.
In two cases, where the original tests showed ELISA positive, RIBA negative, recent RIBA tests were performed which showed positive results, with confirmatory evidence of weak levels of antibody reaction. In both cases, subsequent PCR tests were negative, showing no evidence of current hepatitis C infection. The VRL and the BTSB are currently examining the virological implication of these cases, and their relevance to other cases where original tests showed ELISA positive, RIBA negative results.
There is a further group which requires some examination, namely that group which the BTSB are aware received potentially infected anti-D but who have tested negative for hepatitis C. I have decided to establish a group of experts to make recommendations on the clinical and non-clinical management of this group. While such recipients have been advised of their negative test results, they have not been advised that the product they received was from a potentially infectious source. Currently, information is available from the BTSB on request on the infectivity status of known batches. Issues to be addressed by the Group of Experts will include the psychological implications of directly informing the recipients that they received a potentially infected product, and the question of referral to one of the designated Anti-D clinics. The group will be chaired by the chief medical officer at my Department and will hold its first meeting shortly.
