Brucella canis and use of the ELISA test in humans

The request was successful.

Dear UK Health Security Agency,

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 Buckley

Information Rights, UK Health Security Agency

Dear Ms Buckley,

Thank you for your request which will be handled by the Information Rights Team at the UK Health Security Agency (UKHSA). We acknowledge receipt of your email and request for information, which will be treated as a request for information under statutory access legislation.

Please note that requests under the Freedom of Information Act and the Environmental Information Regulations (EIRs) will receive a response within 20 working days from the day following the date of receipt of your request.

If the request is for your personal data, your request will be handled as a data subject access request (SAR) under Article 15 of the UK General Data Protection Regulation (UK GDPR), then we will respond within one month of the receipt of the request.

We will aim to address all requests promptly and within the required response timeframes. However, when we are unable to meet the response timeframe we will keep requesters updated on a revised expected timescale for a response to their request.

Yours sincerely,

Information Rights Team
Parliamentary and Public Accountability Team
UK Health Security Agency
[UKHSA request email]
http://www.gov.uk/ukhsa Follow us on Twitter @UKHSA

show quoted sections

Dear Information Rights,

I am just following up on this communication as I should had a response by 25.03.2024. Please can you advise?

Yours sincerely,

Dr Buckley

Information Rights, UK Health Security Agency

Dear Ms Buckley,

Thank you for your email and patience whilst we work on your request. We apologies for the delay in providing our response. We are dealing with a high volume of complex requests at this time. We hope to provide you with our response by 12 April.

Thank you once again for your patience.

Yours sincerely,

Information Rights Team
UK Health Security Agency

show quoted sections

Dear Information Rights,

That's fine with me. Thank you for letting me know and I hope you had a good Easter break. I will wait to hear.

Yours sincerely,

Dr Buckley

Information Rights, UK Health Security Agency

2 Attachments

Dear Ms Buckley

 

Please find attached the UK Health Security Agency's response to your
request regarding Brucella Canis and use of the ELISA test in humans at
UKHSA dated 25^th February 2024.

 

Thank you very much for your patience.

 

Yours sincerely,

 

 

[1]UKHSA logo Information Rights Team

UK Health Security Agency

[2][email address]

[3]www.gov.uk/ukhsa Follow us on Twitter @UKHSA

 

 

-----

show quoted sections

References

Visible links
2. mailto:[email address]
3. http://www.gov.uk/ukhsa