COVID-19 Testing Accuracy

Summary

The requester asked for documentation on the specificity and sensitivity of COVID-19 testing procedures used on the Isle of Man in 2021. The Department of Health and Social Care responded by providing a document titled 'SARS-CoV-2 testing on the Isle of Man' and outlining the testing and notification process.

Key Facts

• The Department of Health and Social Care provided a document titled 'SARS-CoV-2 testing on the Isle of Man'.
• The provided document was scheduled to be uploaded to the Isle of Man Government website.
• Swabs are collected at the Grandstand, patient homes, or Nobles by trained practitioners.
• Samples are conveyed to the laboratory regularly.
• The 111 team informs patients of results via text or personally for positive cases.

Data Disclosed

• 2021-01-21
• 2021-02-10
• 1641517
• 111

Original Request

Please send me: The most-recent applicable documentation showing the specificity and the sensitivity of the COVID-19 testing procedures used on the Isle of Man in 2021. a) By "most-recent applicable documentation" I mean the written document (which might be an email, memo, letter, instruction or other document) which shows the relevant information. 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 2021. This includes all forms of COVID-19 tests that have been used by the DHSC in 2021. If any of this information is already is already publicly available, please advise and assist me to locate the information I am seeking, with page references and URLs if necessary. If the release of any of this information is prohibited on the grounds of breach of confidence, I ask that you supply me with copies of the confidentiality agreement and remind you that information should generally not be treated as confidential if such an agreement has not been signed.

Data Tables (1)

Full Response Text

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

Tel: (01624) 642621 Email: dhsc@foi.gov.im Website: www.gov.im/dhsc

Our ref: 1641517 10th February 2021

Dear ###

We write further to your request which was received on the 21st January 2021 and states:

“Please send me: The most-recent applicable documentation showing the specificity and the sensitivity of the COVID-19 testing procedures used on the Isle of Man in 2021. a) By "most-recent applicable documentation" I mean the written document (which might be an email, memo, letter, instruction or other document) which shows the relevant information. 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 2021. This includes all forms of COVID-19 tests that have been used by the DHSC in 2021. If any of this information is already is already publicly available, please advise and assist me to locate the information I am seeking, with page references and URLs if necessary. If the release of any of this information is prohibited on the grounds of breach of confidence, I ask that you supply me with copies of the confidentiality agreement and remind you that information should generally not be treated as confidential if such an agreement has not been signed.”

Our response: a) By "most-recent applicable documentation" I mean the written document (which might be an email, memo, letter, instruction or other document) which shows the relevant information. 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 2021. This includes all forms of COVID-19 tests that have been used by the DHSC in 2021. Please see the attached document “SARS-CoV-2 testing on the Isle of Man”. This document will be loaded onto the Isle of Man Government website in due course. • Swabs are taken either at the Grandstand, patient’s homes or Nobles by trained practitioners and are conveyed to the laboratory regularly. • The 111 team will inform patients of their results by text or personally in the case of positive results. Please quote the reference number 1641517 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.

Yours sincerely

SARS-CoV-2 testing on the Isle of Man

The main platform used on the IOM is a real time PCR with a sensitivity of 98.9% and specificity of 99.1% using the QuantuMDx RT-PCR SARS-CoV-2 Nucleic Acid Detection Test. More details can be found through the company’s website and the Public Health England Technical Validation Report.

This offers three target loci, (S gene, N gene and ORF1 region) which gives 100% coverage of all known SARS-CoV-2 lineages. It also incorporates a human control which identifies nearly all false negatives (due mainly to inadequate swabbing). We have calculated these from previous testing as less than 0.2% of tests.

All positive tests are re-run on an alternative platform with different targets which will identify any false positives.

It is important to have a back-up system and we are using the Hologic Aptima (Panther System) TMA (Transcription Mediated Amplification) SARS-CoV-2 Assay.

This is used worldwide in many testing centres and although TMA is more sensitive than RT-PCR it does not include a human control. However as we are seeing less than 0.2% failure rate on our swabbing, this is not considered a significant issue. Sensitivity is close to 100% and specificity 98.2%. It targets two different regions of the ORF1ab gene in the same reaction.

We also use rapid platforms for confirmatory testing and clinically urgent cases:

Cepheid Xpert Xpress SARS-CoV-2 assay (98% sensitivity, 100% specificity), which targets the N2 and E genes, and;

Biofire FilmArray Respiratory (RP) 2.1 panel (Close to 100% sensitivity and specificity), targets the S and M genes.

Although these are ‘rapid’ tests, the sensitivity / specificity of these are excellent, although they are more expensive and do not lend themselves to high throughput testing.

Additionally, both rapid tests allow us to simultaneously identify other respiratory pathogens that are commonly circulating in order to inform clinicians of the treatment options available to our patients.

We are continuously evaluating other methods and are confident that we are providing a comprehensive and validated testing service for the people of the IOM.