Description of "cases"

Summary

The requester asked for clarification on how 'positive cases' are defined, testing protocols, symptom data, PCR sensitivity, and potential links between vaccination and case increases. The Department of Health and Social Care confirmed that positive cases are based solely on PCR detection, provided technical test specifications, but withheld symptom data and investigation details citing that the information is not held by their department.

Key Facts

• Positive cases are reported based solely on a PCR test detecting SARS-CoV-2, without further testing to confirm illness.
• The main PCR testing platform uses a cycle threshold of 40 cycles with a sensitivity of 98.9%.
• Information regarding the number of symptomatic cases is held by the Public Health Directorate within the Cabinet Office, not the Department of Health and Social Care.
• No investigation into a link between vaccination and case increases was conducted because vaccines do not contain live virus and cannot cause COVID-19.
• Infections in vaccinated age groups are reported as low or very low compared to unvaccinated groups.

Data Disclosed

• 40 cycles
• 98.9%
• 2021-03-11
• 2021-03-19
• 1704405

Exemptions Cited

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

Original Request

1) When "positive cases" are reported are they referring to: a) people who have solely taken a PCR test and it has produced a positive result OR b) people who have produced a positive PCR test result and have then had further testing to confirm they are currently ill with COVID 19. 2) What additional tests are conducted to confirm if an individual currently has COVID 19? 3) How many of the current cases are showing symptoms of COVID 19? 4) What is the sensitivity (cycle threshold) of the PCR tests used in the Isle of Man? 5) Has any link between the sudden increase in cases, following the recent vaccination program rollout, been investigated?

Data Tables (1)

Full Response Text

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

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

Our ref: 1704405 19 March 2021

Dear ###

We write further to your request which was received on 11 March 2021 and which states:

"1) When "positive cases" are reported are they referring to: a) people who have solely taken a PCR test and it has produced a positive result OR b) people who have produced a positive PCR test result and have then had further testing to confirm they are currently ill with COVID 19. 2) What additional tests are conducted to confirm if an individual currently has COVID 19? 3) How many of the current cases are showing symptoms of COVID 19? 4) What is the sensitivity (cycle threshold) of the PCR tests used in the Isle of Man? 5) Has any link between the sudden increase in cases, following the recent vaccination program rollout, been investigated?"

Clarification sought in regard to Q5, Response received: I was wanting to ascertain if the recent increase in "cases" is from people that have also recently been vaccinated. If so, is there a possibility that these two are linked, and would this be something the department would investigate further? Our Response: Question 1 1) When "positive cases" are reported are they referring to: a) people who have solely taken a PCR test and it has produced a positive result or b) people who have produced a positive PCR test result and have then had further testing to confirm they are currently ill with COVID 19.

When "positive cases" are reported they are referring to people who have solely taken a PCR test and it has produced a positive result. Although we don’t report positive/negative, merely whether SARS-CoV-2 has been detected/not detected. Question 2 What additional tests are conducted to confirm if an individual currently has COVID 19? Please see attached document ‘SARS-CoV-2 testing on the Isle of Man’. Question 3 How many of the current cases are showing symptoms of COVID 19? While our aim is to provide information whenever possible, under Section 11(3) (a) of the Act, the Department of Health and Social Care does not hold or cannot, after taking reasonable steps to do so, find the information that you have requested. Collation of information in regard Covid-19 cases is part of the function of the Public Health Directorate which forms part of the Cabinet Office. You may wish to submit a separate Freedom of Information request to the Cabinet Office who may be able to help you. To provide advice and assistance you may find the attached link helpful: https://covid19.gov.im/general-information/latest-updates/ Question 4 What is the sensitivity (cycle threshold) of the PCR tests used in the Isle of Man? Sensitivity and cycle threshold are different things. Please see attached document ‘SARS-CoV-2 testing on the Isle of Man’. The threshold of our main platform is 40 cycles with a sensitivity of 98.9%. Question 5 Has any link between the sudden increase in cases, following the recent vaccination program rollout, been investigated?" Clarification sought in regard to Q5, Response received: “I was wanting to ascertain if the recent increase in "cases" is from people that have also recently been vaccinated. If so, is there a possibility that these two are linked, and would this be something the department would investigate further?” While our aim is to provide information whenever possible, under Section 11(3) (a) of the Act, the Department of Health and Social Care does not hold or cannot, after taking reasonable steps to do so, find the information that you have requested. In regards to your question and in order to provide further context, there is no requirement to carry out an investigation for the following reasons:

• Neither of the vaccinations contain live virus so they cannot give anyone COVID- 19. • The age groups most affected in the current outbreak are those which have not yet been called to receive the vaccine. Infections in the age groups who have been vaccinated are low/very low. This may be related to vaccine protection and/or that older people are not mixing with others to the same extent as younger and therefore not at such a risk of infection. In this regard it should be noted that a) the vaccine is not 100% effective (no vaccine is); b) infections in people who have been vaccinated may be due to i) an infection that was already incubated when they were vaccinated, ii) an infection they caught in the early weeks after vaccination when immune protection had not yet fully developed. Please quote the reference number 1704405 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.

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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 tests where SARS-CoV-2 is detected, 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.