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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鈥檚 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:

/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鈥痑nd 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鈥痯rofessional standards authority)

Acceptable

Trained healthcare professional (i.e. one of the 10 health and social care professional bodies that are overseen by the鈥痯rofessional 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鈥檚 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.鈥� The MHRA is currently looking into a TPP for self-tests.鈥� 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.鈥� 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鈥檚 statements:

Here is the UK Government鈥檚 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鈥痶o understand鈥痓atch to batch variation,鈥痑cceptance of the tests鈥痓y the general鈥痯ublic鈥痑nd鈥痶he effect of鈥痮perator/training effects鈥痷pon鈥痯erformance characteristics.鈥�

he delivery of appropriate training appears important鈥痶o 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鈥檚 鈥渃ovid status鈥�:

2 MHRA鈥檚 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鈥檚 statements:

And this is supported on your website:

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

The鈥疻ANTAI鈥疭ARS-CoV-2 Ab Rapid Test鈥痵hould鈥痭ot be used to diagnose or exclude acute infection鈥痑nd should not be used as the sole basis for鈥痶reatment or patient management decisions.

What does it mean if the specimen tests positive for鈥痑ntibodies against鈥痶he virus that causes COVID-19?鈥疉 positive test鈥痳esult鈥痺ith the WANTAI鈥疭ARS-CoV-2 Ab鈥疪apid Test鈥痠ndicates that antibodies against鈥疭ARS-CoV-2 were鈥痙etected, and the鈥痠ndividual鈥痟as鈥痯otentially been鈥痚xposed to鈥疭ARS-CoV-2.

Due to the risk of false positive results,鈥痗onfirmation of positive results should be鈥痗onsidered 鈥撯€痷sing a second, different antibody鈥痑ssay that detects the same type of antibodies

Laboratory test results should always be considered in鈥痶he context of clinical observations and epidemiological鈥痙ata in making patient management decisions.

False positive results may occur due to cross-reactivity鈥痜rom鈥痯re-existing antibodies or other possible causes

The鈥疎UA鈥痜or this test is in effect for the duration of the鈥疌OVID-19鈥痙eclaration justifying emergency鈥痷se of IVDs,鈥痷nless terminated or revoked鈥�(after which the test may鈥痭o 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鈥檚 reliability.

3 MHRA鈥檚 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鈥檚 questions:

1 - Is the UK Government鈥檚 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?鈥�

MHRA鈥檚 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鈥檚 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鈥痑 recommendation from the manufacturers or from Government advisors, SAGE etc?鈥�

MHRA鈥檚 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鈥檚 plans鈥痜or using鈥痑 single鈥€減ositive鈥� 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 鈥減ositive鈥� test鈥痑 recommendation from鈥痶he manufacturers or from Government advisors, SAGE etc?鈥�?鈥�

MHRA鈥檚 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鈥檚 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/鈥�

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU