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Covid PCR amplification cycles in 2020 and 2021

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Dear Medicines and Healthcare products Regulatory Agency,

Each manufacturer of the Covid PCR test will recommend a differing maximum amplification cycle number when determining the presence of SARS CoV-2, but a maximum of around 40 amplification cycles is typically recommended by test manufacturers.

How many amplification cycles were testing Labs in the UK instructed to do in November 2020? And how many cycles were they doing in March 2021 ?

Has the number of amplification cycles ever changed during the years 2020 and 2021 ?

Yours faithfully,

Chris Richings

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

 

 

Our Ref: FOI 21/584

       

Dear Chris Richings,

       

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

        

Thank you for your enquiry which we received on 28^th May 2021.

  

I confirm that your request is now being handled under the Freedom of
Information Act and you should receive a reply within 20 working days from
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MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

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Telephone 0203 080 6000

 

 

 

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

FOI 21/584

 

Dear Chris Richings,

 

Thank you for your information request, dated 28/05/2021, where you asked
for ‘How many amplification cycles were testing Labs in the UK instructed
to do in November 2020? And how many cycles were they doing in March 2021
?

 

Has the number of amplification cycles ever changed during the years 2020
and 2021 ?’

 

I can confirm that we do not have access to the information that you have
requested and it is likely that it will vary between laboratories
depending on the instructions for use of the different assays that they
use.  You may wish to direct this FOI request to NHS Test and Trace who
should be able to confirm this. 

 

You may find the distribution of CT values in figure S6 of the following
manuscript [1]infectivity_manuscript_20210119_with_figures (ox.ac.uk)
useful, as they seem to suggest that small changes to the upper cut-off
value will have little overall effect on the number of patients diagnosed
with COVID.  The vast majority of patients within this example have CT
values of <30, with very few >35.

 

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Yours sincerely,

 

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

 

 

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