Medical experts believe that women who received infected anti-D, if they avail of the offer of re-testing for hepatitis C, will get the same negative result. However, after consideration, legal advice and much prodding from Positive Action, it was decided that regardless of the apparent lack of risk these women were entitled to know.
The Hepatitis C Expert Group, set up by the Minister for Health, Mr Cowen, realises that these women will be caused further anxiety when they are given the additional information. The re-testing is being offered as a reassurance to them.
Since the publication of the Finlay Hepatitis C Tribunal report it has been clear that the number of women who tested positive for the virus did not correlate with the amount of infected product which was issued by the Blood Transfusion Service Board (BTSB). This meant that either some of the infected product did not transmit infection, or some women who received it have not yet come forward for testing, or a combination of both.
It is not known why some women, when they came forward for testing after the controversy broke in 1994, tested negative. So far, 65,000 women have been tested in the State-wide screening programme. Of those, 1,016 tested positive for hepatitis C.
Just over 19,000 vials of contaminated or potentially contaminated anti-D were administered to women. Of this number, around 6,000 have been identified and will be offered re-testing if they want it. However, the Blood Transfusion Service Board has been unable to contact a further 13,000 women.
Some of these 13,000 may have already been tested but they are not identified by BTSB records as having received one of the infected batches of anti-D. Some may have a different surname or changed address. In some cases hospital records were not adequate.
The expert group, set up in September 1997, looked at the possibility of establishing a register of these women but decided against that because it felt it was not pro-active enough to comply with the BTSB's duty of care to these women.
Instead, it has decided to write to their family doctors, advise them of the situation and offer testing to them. An information pack will be offered to the women and doctors will receive a letter from the consultant hepatologists on the expert group explaining the situation. These women would have originally been tested using an ELISA (enzyme-linked immuno-sorbent assay) test. This tests the blood for antibodies for hepatitis C. This testing method is very sensitive, often picking up false positives. If it is positive, a second test, RIBA (recombinant immunoblot assay), is carried out to confirm the diagnosis.
RIBA is highly accurate in confirming the presence of antibodies to four proteins found in the hepatitis-C virus. If the RIBA test is positive, a PCR test is used to find out whether the virus itself is in the blood. The 6,000 women tested negative on ELISA and it went no further until now. The expert group has decided that an ELISA test will be used again for the women who decide to have a further test. This test, according to the group, is the most sophisticated available and international protocol directs that it be used.
The view of the medical experts advising the group is that there will be no material change in the women's results. The general practitioners involved will also be advised on how to treat any of the 13,000 unidentified women, who may make contact and are worried about their position.
Positive Action has been asking for this move to be made for some time. The BTSB had to be persuaded of the need for these women to be informed. In many instances the board, back in 1994, knew from the women's batch card that they received infected anti-D, although the result of the tests was negative. According to the expert group, the women, since they had tested negative for hepatitis C, were not a priority group for the BTSB. It was concentrating on identifying and tracing the women who had not come forward for testing at all.
At present the expert group is finalising the wording of the documents to be sent to general practitioners. These are due to be sent within the next six to eight weeks.
The situation regarding two other groups of women involved was also examined by the expert group in recent months. The first group was made up of around 30 women who reported an episode of jaundice after receiving anti-D but who tested negative for hepatitis C. These were traced and referred to hepatology units. The next group involved a small number of women who tested positive for the initial ELISA test but were negative for the subsequent RIBA test. At the time this was recorded as a negative result, in line with international practice. These were also offered further testing.
While the BTSB knows that the two batches of anti-D which caused infection came from two different sources - the women known as patient X and patient Y - it is not known if every vial was infected or the level of infection. This may explain why some women became infected and others did not. In some batches the virus may have died. There were thousands more batches of anti-D issued using plasma from patient Y in the 1990s than from patient X in 1977/78. The level of infectivity for the 1990s batch averaged less than 1 per cent, compared with an average of 25 per cent for the earlier batches.
Some women did not become infected; others did but their immune systems spontaneously cleared it. It is not medically understood why this happens. These women are of particular interest to doctors because they want to find out why they responded as they did.
The BTSB's testing programme is still operating for women who have not yet come forward. Meanwhile, in accordance with a recommendation in the Finlay tribunal report, a procedure has been established for the reporting of adverse reactions to blood and blood product by patients. The Department of Health has advised all health boards and hospitals that this system is to be put in place and over 50 positions for transfusion surveillance are to be created.