Dear Liverpool Clinical Laboratories,

It has come to my attention that there have been changes to the diagnostic process in at least some human beings being tested for Brucella canis, and that an ELISA is being used as part of this epidemiological shift in monitoring and/or diagnosis.

I wonder if you could tell me please:

1. Is the ELISA being used for all humans being tested for Brucella canis? If not, what is the decision making process for deciding to do so?

2. Is the ELISA being used the Indirect ELISA that was developed/is run by the APHA?

3. If yes to (2), do they process and run these human samples or does another laboratory? If the the latter, which laboratory(s).

4. If no to (2), which ELISA is being used in humans? Please give me the brand/manufacturer or sign post me to manufacturer datasheets/manual for use.

5. Regardless of the ELISA used, please can you tell me:
a. whether the test is used in a binary (positive/negative) way or whether you also include a third (or more) categories for 'indeterminate/borderline'.
b. what the thresholds are for each of these categories within the test (indicating whether the threshold value stated is the last value of the lower bounded category or the first value of the higher bounded category).

6. Regardless of the ELISA used, please can you tell me:
a. Whether this test was validated for use in humans?
b. If no to (a), how were the thresholds referred to in (5) decided upon?
c. If yes to (a), what is the sensitivity and specificity of this test? And based on what cut off value?
d. If yes to (a), how many humans were used in the validation study? How many high confidence infected, and how many high confidence not infected people were included?

7. If the test is validated for use in humans can you confirm whether:
a. The validation information is published in a peer reviewed paper
b. The validation information is published in another publicly accessible document
c. The validation information is currently being prepared for publication in a peer reviewed paper
d. Or other (please state what)?

8. Does the ELISA being used designed to identify:
a. Brucella canis antigen
b. Brucella canis IgM antibodies
c. Brucella canis IgG antibodies

9. It has come to my attention through a social media forum that a veterinary professional has tested positive only on the ELISA. If any human tests positive on the ELISA only and has no clinical signs/only exposure to a positive dog as a risk factor, please could you indicate how this result would be classified:
a. Currently infected
b. Previously infected
c. Uncertain status and may only reflect previous exposure/infection

10. If any human tests positive on the ELISA only and has no clinical signs/only exposure to a positive dog as a risk factor, please could you indicate what guidance would be given to healthcare professionals working with this individual:
a. Administer antibiotics prophylactically/just in case infected
b. No treatment currently warranted but monitor for evidence of current infection
c. Other (please state what).

11. Do you have any official guidance sheets produced to support the information in (9) and (10)? If yes, please can I have a copy?

Many thanks as always for your help and assistance.

Yours faithfully,

Dr Louise Buckley

lcl communications,

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Dear FOIRequests,

Thank you. Much appreciated.

Yours sincerely,

Dr Buckley