Unused test could have helped reduce hepatitis C transmission in blood

The Department of Health failed to give permission for the implementation of a screening test by the Blood Transfusion Service…

The Department of Health failed to give permission for the implementation of a screening test by the Blood Transfusion Service Board which could have lowered the amount of hepatitis C virus transmitted in blood products.

According to scientific studies, the ALT test could have reduced the transmission of hepatitis C to haemophiliacs receiving blood products by up to 40 per cent, the tribunal was told.

The BTSB sought the approval of the Department for the introduction of the ALT test in July 1987. There followed several letters from the Department querying the cost. Approval for its implementation was never given.

The BTSB's deputy medical director, Dr Emer Lawlor, stated in evidence yesterday that the ALT test should have been introduced. It was introduced in New York in 1982 but it was not considered by the BTSB prior to 1986.

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She said there was disagreement over its efficacy in the early 1980s. It measured ALT levels in a patient and raised levels might be an indication of liver dysfunction, but could also indicate stress or obesity, she said.

In 1986 the BTSB decided to conduct a pilot study using this and another test called anti-HBc, which would detect people who had been exposed to hepatitis B, to see how many donors would be lost if the test was introduced. It found 2.5 per cent of donors would be deferred if it were used.

When the BTSB wrote to the Department of Health seeking its approval to implement the test, it stated that it was already used in Germany, Austria, Italy and Luxembourg.

In a letter to the Department, the BTSB said the incidence of hepatitis C "can be extremely severe in haemophiliacs and the development of this test is necessary in the interest of the good health of haemophiliacs". The cost of introducing it would have been £274,000.

The blood bank emphasised in one letter to the Department in October 1987 that standards less than in other European countries would not be acceptable for Irish patients. The Department continued to ask the BTSB in correspondence to set out the costs involved.

In 1989, when a specific test was developed to detect hepatitis C, the BTSB sought the approval for this test from the Department. It made the application in September 1989 "conscious of claims now being made against the BTSB by haemophiliacs and the lessons we are learning from these claims".

Dr Lawlor said approval was not given to bring in this test either.