Anti-D/Hepatitis C National Screening Programme
The Anti-D/Hepatitis C National Screening Programme was initiated in February 1994 to offer testing to recipients of BTSB Anti-D. While all recipients of BTSB Anti-D were invited to come forward for testing the emphasis was placed on those known to be at significant risk i.e. those that received Anti-D between 1 May 1977 and 31 July 1979. This was later extended to include recipients of this product from 1 March 1991 through to 18 February 1994. More recently the IBTS is targeting recipients of products known to be infectious or potentially infectious who may not yet have come forward for testing.
Recipients are invited to attend their General Practitioner and submit a blood sample. This process is free to patients. General Practitioners are provided with sampling kits by the IBTS to carry out this testing.
The Blood Transfusion Service Board (now the Irish Blood Transfusion Service - IBTS), manufactured Anti-D Immunoglobulin in Ireland from 1971 to February 1994. Anti-D is a blood product that has saved the lives of hundreds of babies by preventing the build up of harmful antibodies in the mother's blood. If a woman with rhesus negative blood gives birth to a baby with rhesus positive blood, there is a risk of Rh antibodies developing causing haemolytic disease of the newborn in a future pregnancy. Anti-D is given to the mother within 72 hours of birth or miscarriage as an injection to prevent this happening.
Hepatitis C Infection of certain Anti-D batches
In Ireland, a total of 190,709 doses were manufactured by the BTSB from 1971 to February 1994. The vast majority of these doses had no risk of infection. Hepatitis C infection of Anti-D product, however, occurred in batches manufactured during the years 1977 and 1978 and a further, smaller outbreak in 1991 to 1994. This became known in February 1994 when the then BTSB identified a serious outbreak of Hepatitis C infection associated with Anti-D Immunoglobulin issued by the BTSB from 1 May 1977 to 31 January 1978 (the last batches expiring on 31 July 1979), and a further, smaller outbreak associated with Anti-D issued between 1 March 1991 and 18 February 1994.
While 65,980 Anti-D recipients have been tested under this programme to date, there is evidence that not all women who received Anti-D during the risk years have been tested. Accordingly, the IBTS is now conducting an extensive search to locate and encourage those women to come forward for testing.
Infectious or potentially infectious Anti-D
A total of 4,062 vials of infectious or potentially infectious Anti-D were manufactured and issued between 1 May 1977 and the end of January 1978 (the expiry date of the latest batches being 31 July 1979) from a plasma pool which was infected with Hepatitis C. Of the 15,833 recipients who indicated exposure to Anti-D from 1977 to 1979, the IBTS have documented records indicating 4,522 actually received Anti D. Of this group, 922 are antibody positive; of whom 459 are PCR positive with viral type consistent with infection though Anti-D. The remainder 3,384 have tested HCV negative.
A total of 14,946 vials of infectious or potentially infectious Anti-D were issued between 1 March 1991 and 18 February 1994 (when the product was withdrawn). Fortunately the infectivity of these batches was very low. Of the 19,045 recipients who indicated exposure to Anti-D in the years 1991 to 1994, the IBTS have documented records indicating 10,558 actually received Anti D. Of this group, 167 are antibody positive of whom 44 are PCR positive with viral type consistent with infection though Anti-D and 10,193 have tested HCV negative.
A small number of infected individuals who had exposure to Anti-D outside the risk years have also been identified. The majority of these also had exposure to blood transfusions and this is likely to be the source of the infection. There is no evidence that Anti-D other than certain batches issued in 1977 to 1979 and 1991 to 1994 was infected.
Who should now be tested?
The IBTS continues to offer and recommend testing to all recipients of Anti-D between 1st May 1977 and the end of July 1979, and 1st March 1991 to 18th February 1994 who have not yet been tested. With regard to the 1977/1978 batches, the period of maximum risk of receiving an infectious batch was between 1st May 1977 and end of September 1978, with the last infectious batch being issued on 26 January 1978. However, the expiry date of the last batch manufactured was 31st July 1979, so that individuals who received Anti-D up to July 1979 should avail of testing.
If you have already been tested for Hepatitis C, please see Anti-D Reassurance Programme, or if you have never been tested, please see Anti-D/Hepatitis C National Screening Programme.
Availability of information on infected batches of Anti-D
The infectious and potentially infectioius batch numbers of Anti-D are now known. In many cases it has been possible to determine the batch number of Anti-D administered to a particular individual from the Anti-D card completed by the doctor who administered the product. Where possible, the IBTS has traced or is still attempting to trace, all such recipients. However, in many cases, the card records are incomplete or unavailable.
Unfortunately also in 50% of cases, hospitals did not return the Anti-D cards to the BTSB. However, the IBTS will continue, with the aid of hospitals, to match a recipient where possible to a batch number. However, as already indicated, this information is often unavailable, so if in doubt, you are encouraged to have the test.