Accuracy of LFD testing regime

Summary

The requester asked for records showing the specificity and sensitivity of COVID-19 testing procedures used on the Isle of Man in October 2021. The Department of Health and Social Care responded that the information is not held by them and may be held by Manx Care.

Key Facts

• The request was received on 2021-11-01 and responded to on 2021-11-11.
• The Department of Health and Social Care does not hold the requested records on LFD testing accuracy.
• The information may be held by Manx Care due to the separation of policy and service delivery.
• The Department was redesigned on 1 April 2021 following Sir Jonathan Michael's Independent Review.
• The requester noted that existing website data covers PCR and TMA tests but lacks LFD specificity/sensitivity data.

Data Disclosed

• 2021-11-01
• 2021-11-11
• 2061789
• 1641517
• 1 April 2021
• October 2021

Exemptions Cited

• Section 11(3)a of the Act (Information not held)

Original Request

I am writing to make a freedom of information request for all the information to which I am entitled under the relevant Freedom of Information provisions. I am an Isle of Man resident. Please send me: "The most-recent records showing the specificity and the sensitivity of the COVID-19 testing procedures used on the Isle of Man in October 2021." a) By "most-recent records" I mean the records (as defined in the Freedom of Information Act) which shows the most-recent information for the current variety of COVID-19 testing procedures. b) By "specificity and sensitivity" I mean those words as usually used by the World Health Organisation and other medical bodies. c) By "the COVID-19 testing procedures used on the Isle of Man in 2021" I mean the full processes (including sample collection, sample testing, and all the way through to patient notification) that have been used by the DHSC on the Isle of Man in October 2021. This includes all forms of COVID-19 tests that have been used by in October 2021. 1) This request is substantially similar to FOI request #1641517. Feel free to re-use any relevant parts of the response that are still applicable. Note that FOI request #1641517 was submitted prior to the widespread use of lateral flow device testing (LFDs). 2) I note the technical data provided online here: https://covid19.gov.im/general-information/testing-results/ a) I note that there is no information on the estimated specificity or sensitivity of LFDs on that web page. b) That web page provides information on the QuantuMDx RT-PCR SARS-CoV-2 Nucleic Acid Detection Test, and the Hologic Aptima (Panther System) TMA (Transcription Mediated Amplification) SARS-CoV-2 Assay, and Cepheid Xpert Xpress SARS-CoV-2 assay, and the Biofire FilmArray Respiratory (RP) 2.1 panel. If the information provided on that website is accurate as it relates to those tests, there is no need to provide any responsive records related to these tests - the existing website information is sufficient.

Data Tables (1)

Full Response Text

Chief Executive: Kathryn Magson Freedom of Information Team Crookall House Demesne Road Douglas Isle of Man IM1 3QA

Our ref: 2061789 11 November 2021

Dear ###

We write further to your request which was received 1st November 2021 and which states: "The most-recent records showing the specificity and the sensitivity of the COVID-19 testing procedures used on the Isle of Man in October 2021." a) By "most-recent records" I mean the records (as defined in the Freedom of Information Act) which shows the most-recent information for the current variety of COVID-19 testing procedures. b) By "specificity and sensitivity" I mean those words as usually used by the World Health Organisation and other medical bodies. c) By "the COVID-19 testing procedures used on the Isle of Man in 2021" I mean the full processes (including sample collection, sample testing, and all the way through to patient notification) that have been used by the DHSC on the Isle of Man in October 2021. This includes all forms of COVID-19 tests that have been used by in October 2021. 1) This request is substantially similar to FOI request #1641517. Feel free to re-use any relevant parts of the response that are still applicable. Note that FOI request

1641517 was submitted prior to the widespread use of lateral flow device testing

(LFDs). 2) I note the technical data provided online here: https://covid19.gov.im/general- information/testing-results/ a) I note that there is no information on the estimated specificity or sensitivity of LFDs on that web page. b) That web page provides information on the QuantuMDx RT-PCR SARS-CoV-2 Nucleic Acid Detection Test, and the Hologic Aptima (Panther System) TMA (Transcription Mediated Amplification) SARS-CoV-2 Assay, and Cepheid Xpert Xpress SARS-CoV-2 assay, and the Biofire FilmArray Respiratory (RP) 2.1 panel. If the information provided on that website is accurate as it relates to those

tests, there is no need to provide any responsive records related to these tests - the existing website information is sufficient."

Our response: While our aim is to provide information whenever possible, in this instance the Department of Health and Social Care ('the Department') is unable to provide the information that you have requested. This is in line with Section 11(3)a of the Act, as a practical refusal reason applies; namely we do not hold or cannot, after taking reasonable steps to do so, find the information that you have requested as it may be held by Manx Care. You may wish to re-submit your request to Manx Care which is an option available on the Freedom of Information request portal, who may be able to help you. To provide advice and assistance, the Department of Health and Social Care redesigned on 1 April 2021 as a direct result of Sir Jonathan Michael’s Independent Review of the Isle of Manx Health and Care System. This Review continues to be a catalyst for change and improved service provision. The redesigned Department ensures the separation between the setting of policy and strategy and the delivery of services by Manx Care.

Please quote the reference number 2061789 in any future communications.

Your right to request a review

If you are unhappy with this response to your freedom of information request, you may ask us to carry out an internal review of the response, by completing a complaint form and submitting it electronically or by delivery/post.

An electronic version of our complaint form can be found by going to our website at https://services.gov.im/freedom-of-information/Review . If you would like a paper version of our complaint form to be sent to you by post, please contact me and I will be happy to arrange for this. Your review request should explain why you are dissatisfied with this response, and should be made as soon as practicable. We will respond as soon as the review has been concluded.

If you are not satisfied with the result of the review, you then have the right to appeal to the Information Commissioner for a decision on; 1. Whether we have responded to your request for information in accordance with Part 2 of the Freedom of Information Act 2015; or 2. Whether we are justified in refusing to give you the information requested.
In response to an application for review, the Information Commissioner may, at any time, attempt to resolve a matter by negotiation, conciliation, mediation or another form of alternative dispute resolution and will have regard to any outcome of this in making any subsequent decision.

More detailed information on your right to a review can be found on the Information Commissioner’s website at www.inforights.im. Should you have any queries concerning this letter, please do not hesitate to contact me. Further information about freedom of information requests can be found at www.gov.im/foi.

I will now close your request as of this date.