FOI release

Freedom of Information request about COVID-19 testing (FOI-21/355)

Published 28 May 2021

Thank you for your email of 05 April 2021 With questions about the testing for SARS-CoV-2. Please see our comments and answers below.

1 Enquirer’s statements:

During my research I came across this UK Government document and it covers all lateral flow devices and RT-PCR test by any manufacturer:

https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-point-of-care-sars-cov-2-detection-tests

It says:

Sample type

Desired

Sputum, saliva or other method not using invasive swab

Acceptable

Nasopharyngeal or oropharyngeal swabs, lower respiratory tract aspirates, bronchoalveolar lavage, nasopharyngeal wash/aspirate or nasal aspirate

Comment

Methods not using invasive swabs are desirable due to patient discomfort, pre-analytical errors and issues with supply chain.

So any test that swabs deep into the nose and mouth is 2nd choice at best and has too many problems associated with it.

The same document also states:

Target user

Desired

Trained healthcare professional (i.e. one of the 10 health and social care professional bodies that are overseen by the professional standards authority)

Acceptable

Trained healthcare professional (i.e. one of the 10 health and social care professional bodies that are overseen by the professional standards authority)

Comment

A healthcare professional will select the right test to use with the patient, perform the test and then interpret and communicate the results. There may be some scope for supervised self-sampling where the sample collection device is CE marked for this purpose (eg. saliva samples).

Full training appropriate to the intended user is required.

1 MHRA’s comments:

The MHRA Target Product Profile (TPP) for point of care tests (which include Covid-19 tests) does not apply to self-tests. It only applies to professional use tests.  The MHRA is currently looking into a TPP for self-tests.  TPPs are aspirational documents, intended to guide manufacturers to develop tests with desirable and acceptable characteristics. As such, whilst it may be desirable for tests to not use a swab sample, they are acceptable and, in many cases, have been shown to have superior performance to currently available tests using saliva or other non-invasive sample types.  Clinical studies and post-market surveillance data from swab test use suggests that they are safe and well-tolerated by the general public.

2 Enquirer’s statements:

Here is the UK Government’s analysis of the Innova LFD test:

https://www.ox.ac.uk/sites/files/oxford/media_wysiwyg/UK%20evaluation_PHE%20Porton%20Down%20%20University%20of%20Oxford_final.pdf

It says:

issues need to be addressed to understand batch to batch variation, acceptance of the tests by the general public and the effect of operator/training effects upon performance characteristics. 

he delivery of appropriate training appears important to test performance.

So preferably only trained registered medical people should use it and at unsupervised at home use is not advised nor is the use of a single positive result the only method to determine the subject’s “covid status”:

2 MHRA’s comments:

The Innova test and its associated instructions for use etc are intended for professional use.

The NHS Test and Trace COVID-19 self-test is similar to the Innova professional use test, however there are some important differences. This includes instructions for use which are suitable for lay users to follow in order to use the test correctly.

3 Enquirer’s statements:

And this is supported on your website:

https://innovala.com/en/img/FDA/EUA-Wantai-rapid-hcp.pdf

The WANTAI SARS-CoV-2 Ab Rapid Test should not be used to diagnose or exclude acute infection and should not be used as the sole basis for treatment or patient management decisions.

What does it mean if the specimen tests positive for antibodies against the virus that causes COVID-19? A positive test result with the WANTAI SARS-CoV-2 Ab Rapid Test indicates that antibodies against SARS-CoV-2 were detected, and the individual has potentially been exposed to SARS-CoV-2.

Due to the risk of false positive results, confirmation of positive results should be considered – using a second, different antibody assay that detects the same type of antibodies

Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making patient management decisions.

False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes

The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used)

So not to be used as the sole reason for deciding if someone has the virus or not, it cross reacts with other causes and untrained personnel taking the samples and running the tests are the biggest problem with it’s reliability.

3 MHRA’s comments:

The website quoted (https://innovala.com/en/img/FDA/EUA-Wantai-rapid-hcp.pdf) is not linked to the MHRA. The link goes to a guidance document which appears to have originated in the USA and may be linked to the work of the US Center for Disease Control or the FDA, the regulator for medical devices in the USA. The test described in the document is an antibody test. It is not the same test being offered to the public in the UK by NHS Test and Trace/ Department of Health and Social Care (DHSC).

Enquirer’s questions:

1 - Is the UK Government’s plans for sending the test kits to people at home for unsupervised use by untrained persons using a second choice sampling method a recommendation from the manufacturers or from Government advisors, SAGE etc? 

MHRA’s reply: this is outside the remit of the MHRA. Please send this question to the Department of Health and Social Care (DHSC) through freedomofinformation@dhsc.gov.uk

2 - What is the reasoning for using the invasive method for taking samples and not the saliva/sputum option which is desired?

MHRA’s reply: this is outside the remit of the MHRA. Please send this question to the Department of Health and Social Care (DHSC) through freedomofinformation@dhsc.gov.uk

3 - Was this decision about the sampling method a recommendation from the manufacturers or from Government advisors, SAGE etc? 

MHRA’s reply:

The legal manufacturer of any test is responsible for stating in their instructions for use which specimen type and method of collecting the specimen is required for their test. The manufacturer must hold evidence to support the intended use and performance of their test before they can market the device. The specimen type and collection method cannot be changed or updated by any other organisation.

4 - Is the UK Government’s plans for using a single “positive” test result that is not to be followed up with a 2nd different type of test nor any other medical checks to confirm the validity of the original “positive” test a recommendation from the manufacturers or from Government advisors, SAGE etc? ? 

MHRA’s reply: this is outside the remit of the MHRA. Please send this question to the Department of Health and Social Care (DHSC) through freedomofinformation@dhsc.gov.uk

5 - Were the manufacturers involved in this decision making process at all on these subjects?

MHRA’s reply:

The legal manufacturer of the NHS Test and Trace COVID-19 self-tests is the DHSC. Please send this question to the Department of Health and Social Care (DHSC) through freedomofinformation@dhsc.gov.uk

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It 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/ 

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU