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There was a shift in the NHS funding model which took place in 1991, from centralised and area funding provided by the Department of Health and regional health authorities, to an internal market system.

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John Canavan stated that reference to the HCV screening being marginal in terms of cost benefit by the Department of Health related to the economic cost-benefit and not the public health benefit.

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There was HCV testing under development and Dr Gunson and Dr Barbara were told that clinical trials would soon begin. They agreed to conduct a UK study, with 1,000 samples to be sent from the UK to Chiron for blind testing.

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Dr Gunson wrote to Dr M E Smith to agree to conduct a UK study, with 1,000 samples to be sent from the UK to Chiron for blind testing relating to HCV.

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A report by Dr Barbara drafted the relevant protocols for the provision of testing kits and to undertake anti-HCV testing on samples for discussion at a further meeting with Ortho on 29 March 1989.

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Professor Cash wrote to Dr Gunson to ask whether Dr Barbara might be persuaded to include SNBTS samples which had been tested for ALT in the North London Blood Transfusion Centre anti-HCV screening trial.

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"The Guardian" wrote that the most immediate concern facing the Department of Health was how to set up a mechanism and find the staff to tell donors the implications of carrying Hepatitis C antibodies.

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Dr Dow had used the new generation Abbott ELISA to retest the 69 reactive samples from the multi-centre study. Only 7 were repeatedly reactive, including the 6 which had previously tested positive under supplemental RIBA and PCR testing. The new generation test was likely to be more specific and cause fewer false positive results.

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Dr Gunson confirmed he approved the new generation Abbott Hepatitis C antibody test.

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To accommodate the slippage of the unavailability of test kits, Mr Macleod and Dr Metters postponed the introduction of routine anti-HCV screening until 1 September 1991.

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Dr Rejman wrote to Dr Gunson requesting amendments to the article to mitigate criticism relating to the timeline for introducing screening, and specifically the delay due to lack of supplementary testing.

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Dr Gunson did not believe any delay was caused by RIBA II not being available but it was due to the logistics of transferring samples from three RTCs to each of their confirmatory laboratories and the fact that 65 PCRs took a long time to complete.

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A full report of the Ortho and Abbott trial was produced by Dr Edward Follett in Glasgow.

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3,282 samples screened for ALT and anti-HBc in the NBTS three-centre study had been tested using the first-generation Chiron/Ortho ELISA test and the test was considered to be reproducible, robust and meaningful, but further study was needed.

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HCV Screening under Chiron showed effectiveness at testing when samples from North London Blood Transfusion Centre donations had tested positive when blind tested.

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ACVSB met for the first time on 4 April 1989, chaired by Dr Harris. ACVSB's role was to give advice to the UK health ministers and would focus on the major policy issues with the implementation of the policy being for others. The issue of anti-HCV testing was not covered specifically.

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Denmark, Sweden and Finland were trialling the Chiron/Ortho anti-HCV test, and several other countries were planning to do so.

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Dr Tuddenham wrote to John Canavan to support the move to evaluate the test based on detection of antibody to polypeptide synthesised by recombinant yeast clones of the HCV virus. This is because screening donor blood by such an assay could reduce the transmission rate of non-A non-B Hepatitis in single donor products and in some pooled plasma derivatives.

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Dr Lane wrote to Dr Rejman that the presence of antibody for Hepatitis C was not necessarily a marker of infectivity in HCV screening. However, Dr Gunson and the ACTTD were reporting the opposite of this, which Dr Mortimer and Professor Cash appeared to endorse.

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In a letter to Dr Rejman, Professor Arie Zuckerman stated that despite the projected costs of the screening test, the introduction of screening could not be delayed much beyond FDA approval considering the overall morbidity of chronic non-A non-B Hepatitis (including apparently autoimmune liver disease and hepatocellular carcinoma), and litigation which would be indefensible.

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