Dear Liverpool Clinical Laboratories,

Thank you for responding to my earlier FOI request, and this request is a follow up query in respect of this response.
The original request and reply can be found here: https://www.whatdotheyknow.com/request/b...

You mention in part 7.b the following "As this assay is being used to test human sera in an invalidated and novel way, conservative thresholds were chosen that maintained 100% specificity in the control/negative samples."

And I wondered if I could have more information on this aspect of the decision making:
1. You mention thresholds were chosen that maintained 100% specificity in the control/negative samples, but also report that this test has not been validated. Therefore, I wondered if you could tell me:
a. How many control/negative individual human's (to avoid pseudo-replication) blood samples were used to determine this threshold referred to in 7b?
b. How you avoided circular reasoning here because if specificity was derived from negative samples only, this would imply that it will always be 100% specific by definition? Or do you mean negative on a different Brucella canis test (if so, which one)?
d. Is there a paper trail to support discussions to deviate from the threshold of 1.47 set for the APHA iELISA as validated for use in dogs given the lack of validation studies for its use in humans?

2. Please can also tell me the cut offs you are currently using for the SAT test for Brucella canis, when using this test with humans, including for both a equivocal and positive result?

Thank you for all your hard work around Brucella canis and this FOI is primarily to ensure transparency, comprehension and understanding of any further reports of people, particularly veterinary staff, testing positive for Brucella canis to ensure that human-animal bonds are not being unnecessarily severed by the recommendations of potentially overzealous and frightened veterinary professionals.

Yours faithfully,

Dr Buckley

lcl communications,

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FOIRequests,

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Freedom of Information Act 2000 – Request for Information Ref: 9879

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Freedom of Information Act 2000 – Request for Information Ref: REF 9879

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