FOI release

Freedom of Information request on Zhejiang Orient Gene Biotech Rapid COVID-19 (Antigen) Self-test (FOI 21/749)

Published 29 December 2021

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-26-july-2021/freedom-of-information-request-on-zhejiang-orient-gene-biotech-rapid-covid-19-antigen-self-test-foi-21749

29th July 2021

FOI 21/749

Dear

Thank you for your information request, dated 30th June. In your email you referred to the Zhejiang Orient Gene Biotech Rapid COVID-19 (Antigen) Self-test with the MHRA reference number DEU/005/2021/002 and requested:

  1. Please supply all the documentation and studies supplied by the manufacturer to the MHRA that shows that the device has been proven to give equally accurate results on symptomatic persons with high viral loads compared to it’s use on asymptomatic persons with low viral loads

  2. Please supply all the documentation and studies supplied by the manufacturer to the MHRA that shows that the device has been proven to give accurate results in times of low prevalence of covid-19 in the population

  3. Please supply all the documentation and studies supplied by the manufacturer to the MHRA that shows that the device has been proven to give equally accurate results on persons who have the swab taken by trained, registered medical personnel who are registered as per the Government’s targeted product profile for covid-19 tests when compared to those persons who are untrained and self-swab unsupervised or whom are swabbed by non-medical personnel

Unfortunately, the information requested in points 1, 2 and 3 is exempt from release under Section 44:

Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested:

  • constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.
  • relates to the affairs of businesses which continues to exist.

On that basis we are satisfied that section 44 of FOI Act apply, and the information is exempt from release.

We recommend that you contact the legal manufacturer or their UK Responsible Person directly with regards to these requests who may be able to offer you more information.

With regards to question 4 which asked for an explanation of what the following quote from the manufacturer’s website means: “The Coronavirus Ag Rapid Test Cassette (Swab) detects but does not differentiate between SARS-CoV and SARS-CoV-2.”. This means that the test is able to detect the presence of the proteins found in both the SARS-CoV and SARS-CoV-2 viruses. A positive test result indicates that the individual may have either COVID-19 disease (associated with the SARS-CoV-2 virus) or a different coronavirus known as SARS-CoV. The test cassette cannot provide a result which indicates which virus is present in the sample which has been tested. However, as there is currently not a known outbreak of SARs-CoV, nor do we consider this to be likely in the near future, the risk to public health posed by the cross-reactivity of this assay to SARs-CoV is very low, if not negligible. In the event of any positive test result, the government guidelines regarding reporting of the test result and self-isolating should be followed.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk.

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 online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/

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

Please remember to quote the reference number above in any future communications.

Yours sincerely

MHRA Customer Service Centre

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