Information regarding Polymerase Chain Reaction (PCR) testing use for Isle of Man samples.

Summary

The request sought details on PCR testing kits, sensitivity, accuracy, and error rates used in the Isle of Man. The Department of Health and Social Care disclosed the manufacturer, cycle threshold, and accuracy percentages, but refused to provide specific figures for false positives and negatives citing lack of data.

Key Facts

• The PCR testing kit used is the QuantuMDx RT-PCR SARS-CoV-2 Nucleic Acid Detection Test.
• The Cycle Threshold (sensitivity) for the tests is set at 40.
• The reported test accuracy is 98.9% sensitivity and 99.1% specificity.
• Accuracy is monitored through regular internal and external quality assessments.
• The Department does not hold specific figures for false positives or false negatives.

Data Disclosed

• 40
• 98.9%
• 99.1%
• 2021-01-25
• 2021-02-18
• 1643449

Exemptions Cited

• Section 11(3)a of the Freedom of Information Act 2015 (practical refusal: information not held or cannot be found after reasonable steps)

Original Request

Question 1: Who manufactures, and supplies the Polymerase Chain Reaction (PCR) Testing kits in use in the Isle of Man? Question 2: What is the sensitivity (cycle threshold) of the PCR tests conducted in Isle of Man? Question 3: What analysis of the sensitivity (cycle threshold) has been undertaken to ensure that it is correct? Question 4: What is the accuracy of the PCR tests in percentage? Question 5: What data is available or used to measure the PCR test accuracy? Question 6: How is the accuracy of the PCR tests monitored? Question 7: How many false positives have the PCR tests returned? Question 8: How many false negatives have the PCR tests returned?

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: 1643449 17th February 2021

Dear ###

We write further to your request which was received on the 25th January 2021 and states:

“Question 1: Who manufactures, and supplies the Polymerase Chain Reaction (PCR) Testing kits in use in the Isle of Man? Question 2: What is the sensitivity (cycle threshold) of the PCR tests conducted in Isle of Man? Question 3: What analysis of the sensitivity (cycle threshold) has been undertaken to ensure that it is correct? Question 4: What is the accuracy of the PCR tests in percentage? Question 5: What data is available or used to measure the PCR test accuracy? Question 6: How is the accuracy of the PCR tests monitored? Question 7: How many false positives have the PCR tests returned? Question 8: How many false negatives have the PCR tests returned?”

Our response: Question 1: Who manufactures, and supplies the Polymerase Chain Reaction (PCR) Testing kits in use in the Isle of Man? The Department uses 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 Question 2: What is the sensitivity (cycle threshold) of the PCR tests conducted in Isle of Man? The Cycle Threshold is 40, more details can be found using the link to the report above. Question 3: What analysis of the sensitivity (cycle threshold) has been undertaken to ensure that it is correct? Details of the sensitivity (cycle threshold) can be found using the link to the report above. Question 4: What is the accuracy of the PCR tests in percentage? The accuracy of the PCR tests are: Sensitivity of 98.9% and Specificity of 99.1%. Question 5: What data is available or used to measure the PCR test accuracy? Data is available using the link to the report in question 1. Question 6: How is the accuracy of the PCR tests monitored? The Department runs regular internal and external quality assessment material. Question 7: How many false positives have the PCR tests returned? 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.

The Department does not keep the figures for the number of false positives however all positive tests are re-run on an alternative platform with different targets which will identify any false positives. Question 8: How many false negatives have the PCR tests returned? 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. The Department does not keep the figures for the number of returned false negative tests however the Department incorporates a human control which identifies nearly all false negatives (due mainly to inadequate swabbing).

Please quote the reference number 1643449 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 faithfully