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A potentially infected Armour batch was not reported to the DHSS. The letter concerned the follow up of a potentially contaminated batch of Factorate before it was removed from the market

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In notes on an informal meeting with the DHSS, Clive Collins noted that the HTLV-3 viral inactivation studies needed to be repeated.

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Dr Alfred Prince, an eminent virologist, had conducted viral inactivation tests on Armour's product.

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Dr Prince reported in his findings after conducting viral inactivation tests on Armour's product that higher inactivation process efficacy could not be demonstrated in this experiment due to the unexpectedly low titer of the virus stock employed.

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In a letter, Armour had learned that a batch of heat-treated Factorate, to which a donor who had subsequently developed AIDS was known to have contributed, had been distributed to eight centres in the UK.

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Alpha Pharmaceuticals disclosed the results of tests which showed that their heating processes had inactivated HTLV-3/HIV virus load to a degree sufficient to show they were effectively safe. This information was published in a leaflet disclosed to patients.

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Armour was informed that a patient in Lewisham had seroconverted after receiving a dose from a heat treated batch and noted that "This patient is the first to show sero-conversion from HTLV-III negative to positive following administration of the batch of Factorate Heat Treated in question".

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Dr Peter Jones told a conference in Newcastle of suspected seroconversions of HIV after using the Armour produced Factor 8 in the Netherlands and the US.

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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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