Understanding PCR Cut Offs in pillar 2 community testing

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Dear Department of Health and Social Care,

I am a public health researcher for a local government authority and I attempting to understand the current provision for PCR testing for Sars-CoV-2, specifically around pillar 2 community testing and CT cut offs in how this affects a positive diagnosis.

Referring to the PHE guidance document: ‘Understanding cycle threshold (Ct) in SARS-CoV-2 RT-PCR’ (28/10/2020), my request is based on the following extracts:

1. “There are many different SARS-CoV-2 RT-PCR assays/platforms in use across the UK.” (p5)
2. “A typical RT-PCR assay will have a maximum of 40 thermal cycles… A 3-point increase in Ct value is roughly equivalent to a 10-fold decrease in the quantity of viral genetic material.” (p6)
3. “Ct values can be used as a more quantitative technique to accurately measure the number of viral copies per cell in the original sample… Most diagnostic laboratories do not routinely perform this quantification for respiratory viral swabs.” (p6)
4. “Ct values are not provided for all SARS-CoV-2 molecular detection methods. Some commercial RT-PCR techniques are closed 'black box' systems whereby the operator cannot observe the reaction in real-time and the result is interpreted by software into a qualitative non-interrogatable positive or negative result.” (p7)

Referring to those specific points, I would therefore like to know the following information for pillar 2 test providers/labs commissioned in England:

1. How many different providers are currently conducting PCR tests for the pillar 2 programme? (By region if possible).
2. What are the maximum cycle cut-offs for each of these assays/platforms?
3. Do any of these laboratories incorporate CT-level analysis to support their diagnosis?
4. How many providers are operating a “black box” (or similar) approach, and what are their CT cut off limits for their tests?

and finally 5. Does the DHSC make/acknowledge any distinction between PCR positives with very high CT cut offs, and very low CT cut offs?

I have previously requested this information from PHE, who suggested I try the NHS, and then NHE England, who suggested I try the DHSC. I am hoping that you - of all departments carry information on pillar 2 community testing, as surely someone must be.

Yours faithfully,
Robert

Department of Health and Social Care

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Dear Department of Health and Social Care,
Understandably you are very busy with the Covid response and I fully thank you for your efforts over this past year. I had originally asked Public Health England for this information and they referred me to NHS England, who referred me to you.
Are you able to state at the least if you hold this information. If you do not hold it then I can try other avenues. If no one holds it then this raises other questions regarding how the Covid response is being overseen by the central department.

Yours faithfully,

Robert Whitehead

Dear Department of Health and Social Care,
I have not received a reply from your office, in the 28 days since I sent you a reminder, requesting a response to my FOI request (originally dated 18/12/2020). I initially had hoped that the UK DHSC would hold this information on what tests they are using to run the community surveillance, and how these align with the PHE summary cited. I would hope that someone in government is keeping an eye on Covid testing assays, to this level; unless It is an unregulated free-for-all.
Are you able to state at the least that you hold this information and are taking time to put it together? If you do not hold it then you can recommend other avenues. If no one holds it then this raises other questions regarding how the Covid response is being overseen by the central department.

If you can not at least reply, saying that the DHSC does not hold this information, then I will have to refer this request to the Information Commissioner.

Yours faithfully,
Robert Whitehead

Department of Health and Social Care

1 Attachment

Dear Mr Whitehead,

Please find attached the Department of Health and Social Care's response
to your recent FOI request (our ref:FOI-1282926) and I apologise for the
delay.

Yours sincerely, 

Hazel Percy
Freedom of Information Team
Department of Health and Social Care

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