FOI release

Freedom of Information request about PCR Swab Test Accuracy SARS-CoV-2 Parts 1 & 2 (FOI-21-153)

Published 24 March 2021

Thank you for your 2 emails of 21 January 2021 entitled ‘Freedom of Information request - PCR Swab Test Accuracy SARS-CoV-2 Part 1’ and ‘Freedom of Information request - PCR Swab Test Accuracy SARS-CoV-2 Part 2 Final’

This reply is for the questions in both emails.

The PCR swab tests being used by NHS laboratories are not 100% accurate in the detection SARs-CoV-2.

Meta-analysis suggests that they are likely to be in the region of 90% sensitive, missing around 1 in 10 positive samples, although this differs from test to test.

However, the overall specificity of the tests is generally very good, close to 100.

See Diagnostic Performance of CT and Reverse Transcriptase Polymerase Chain Reaction for Coronavirus Disease 2019: A Meta-Analysis - PubMed (nih.gov)

Kary Mullis was a Nobel prize winning biochemist who invented the polymerase chain reaction (PCR) method. He did not invent an RT-PCR test for SARs-CoV-2.

Kary Mullis died on 07 August 2019 before the first case of SARs-CoV-2 was identified.

The current generation of RT-PCR tests used in the detection of many diseases and disease states are good demonstrations of the application of the polymerase chain reaction technique.

If you have a query about the information provided, please reply to this email.

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If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

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SK9 5AF

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

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