Dear Public Health England,

This is a request for information pursuant section 1 Freedom of Information Act (FOIA) 2000.

Please provide the following information as recorded and held by Public Health England.

1. The validation study for each of the RT-PCR and Rapid Lateral Flow tests currently in use on or in England.

2. The known error/accuracy rate.

3. Information demonstrating that the RT-PCR and Rapid Lateral Flow tests are diagnostic instruments contrary to manufacturer literature.

4. The Cycle threshold for the RT-PCR test in laboratories under the superintendence of Public Health England.

5. The genetic sequence UNIQUE to SARS-CoV-2 and not the sequence currently used which show up 93 times in the Human genome and 91 times in Bacteria and Fungi (microbe) genomes.

6. In isolating and purifying SARS-CoV-2 from a COVID-19 patient sample, please provide a copy of the negative control experiments to rule out other possibilities of disease causation such as toxicity, trauma and malnutrition etc.

Yours faithfully,

P Newton

FOI, Public Health England

OFFICIAL

Dear P. Newton,

We acknowledge receipt of your email and request for information, which will be treated as a request for information under statutory access legislation.

Please note that requests under the Freedom of Information Act and the Environmental Information Regulations (EIRs) will receive a response within 20 working days from the day following the date of receipt of your request.

If the request is for your personal data, your request has been handled as a data subject access request (SAR) under Article 15 of the General Data Protection Regulation (GDPR), then we will respond within one month of the receipt of the request.

Public Health England (PHE) is responsible for providing guidance and advice to government and front-line services for all aspects of public health. It is a designated Category 1 responder organisation under the Civil Contingency Act and this specifically includes the COVID-19 response, providing clinical expertise and wider public health advice and guidance across national and local government, the NHS and third sector. As such, you may experience delays when making statutory information access requests during the pandemic.

We will aim to address all requests promptly and within the required response timeframes. However when we are unable to meet the response timeframe we will keep requesters updated on a revised expected timescale for a response to their request. The Information Commissioner recognises this position in its recent guidance, see link: https://ico.org.uk/media/2617613/ico-reg...

Public Accountability Unit
Public Health England
[Public Health England request email]
www.gov.uk/phe Follow us on Twitter @PHE UK

dangos adrannau a ddyfynnir

FOI, Public Health England

OFFICIAL
Dear P. Newton,

Public Health England (PHE) partially holds the information as specified by your request.

Under Section 16 of the Freedom of Information Act, a public authority has a duty to provide advice and assistance. Accordingly, we have provided information to support our request and provided links to information external of PHE relevant to the information you have requested.

There are multiple PCR tests being used and every kit will have its own interpretative criteria and thresholds, as recommended by the manufacturer. There are at least 80 different platforms in use, configured in various ways in different laboratories. Some test provides Ct values some does not.

Range, mean, median for thresholds will be dependent on the operating arrangements in each laboratory and relate to each kit/assay being used. These laboratories have a statutory duty to report positive cases to PHE, but they are not obliged to advise PHE which tests they are using nor submit CT values used to PHE.

Cycle threshold (Ct) cut offs for covid-19 PCR tests are subjected to a standardised laboratory algorithm and this informs interpretation of positive or negative results. The algorithm is based on evaluating the limit of detection for each test using known positive control material and will differ depending on the assay used.

These data are available from the commercial manufacturer of the assay and is subject to local validation by the laboratory using the test and before using it for diagnostic purposes. The laboratories have a statutory duty to report positive cases to PHE, but they are not obliged to advise PHE which tests they are using nor submit CT values used to PHE. All testing laboratories are also expected participate in external quality assurance schemes and their quality is thus monitored.

Further information on understanding cycle threshold (Ct) in SARS-CoV-2 RT-PCR can be found at the following link. https://assets.publishing.service.gov.uk...

Furthermore, PHE does not mandate what each lab needs to do - we provide guidance - the assessment of quality is performed by UKAS (UK accreditation service). Should you wish to contact them regarding accreditation you can do so at: [email address] or you can view their accreditation page at: https://www.ukas.com/find-an-organisation/

Lateral flow tests show high specificity and are effective at identifying most individuals who are infectious, Oxford University and a PHE evaluation confirmed.

The specificity of the test was recorded as 99.68% - the overall false positive rate was 0.32%, although this was lowered to 0.06% in a lab setting.

It has an overall sensitivity of 76.8% for all PCR positive individuals but detects over 95% of individuals with high viral loads, and minimal difference between the ability of the test to pick up viral antigens in symptomatic and asymptomatic individuals.

You can view this here: https://www.ox.ac.uk/news/2020-11-11-oxf...

The Virus Reference Laboratory at PHE, Colindale, London has grown the virus, SARS-CoV-2. The virus culture method has been published in the following peer reviewed paper: https://www.eurosurveillance.org/content...

Virus is detected from samples by molecular methods or Lateral Flow devices. Isolation of the actual virus is highly specialised work and must take place in a suitable containment laboratory using cell culture techniques.

PHE's virology teams use the term "virus isolation" to mean culture of SARS-CoV-2 in the laboratory. This specialised technique involves adding patient samples to cell cultures and looking for virus growth. It is time consuming and highly specialised work. For this reason, the SARS-CoV-2 virus is identified most often by looking for its unique genetic material in a clinical sample and further identification is refined and confirmed by whole genome sequencing.

PHE' culture work on other SARS-CoV-2 variants is in progress and has not published in any peer-reviewed papers at present.

Accordingly, please find the following links below regarding evidence of COVID-19: SARS-CoV-2 has been cultured and then subjected to electron microscopy. Evidence of the Electron Micrograph is available at the following link: https://publichealthmatters.blog.gov.uk/...

General information pertaining to SARS-CoV-2, which causes the disease known as COVID-19: https://www.gov.uk/government/publicatio...

'Finding the evidence: Coronavirus': https://phelibrary.koha.ptfs.co.uk/coron...

The collection of 'Scientific evidence supporting the government response to coronavirus (COVID-19): https://www.gov.uk/government/collection...

You may also wish to view the below for further information.

COVID-19 variants: genomically confirmed case numbers: https://www.gov.uk/government/publicatio...

Investigation of SARS-CoV-2 variants of concern: technical briefings: https://www.gov.uk/government/publicatio...

Yours sincerely,
FOI Team

Public Accountability Unit
Public Health England
[Public Health England request email]
www.gov.uk/phe Follow us on Twitter @PHE UK

dangos adrannau a ddyfynnir

Dear Public Health England,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Public Health England's handling of my FOI request 'PCR and Lateral flow test.'.

Despite PHE attempting to divert from truth principles, the PHE request remains inconclusive.

Please provide the information point for point.

1. The validation study for each of the RT-PCR and Rapid Lateral Flow tests currently in use on or in England.

2. The known error/accuracy rate.

3. Information demonstrating that the RT-PCR and Rapid Lateral Flow tests are diagnostic instruments contrary to manufacturer literature.

4. The Cycle threshold for the RT-PCR test in laboratories under the superintendence of Public Health England.

5. The genetic sequence UNIQUE to SARS-CoV-2 and not the sequence currently used which show up 93 times in the Human genome and 91 times in Bacteria and Fungi (microbe) genomes.

6. In isolating and purifying SARS-CoV-2 from a COVID-19 patient sample, please provide a copy of the negative control experiments to rule out other possibilities of disease causation such as toxicity, trauma and malnutrition etc.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/p...

Yours faithfully,

P Newton

FOI, Public Health England

OFFICIAL

Dear P. Newton,

We acknowledge receipt of your email, which will be treated as a request for an internal review, following your request for information under the Freedom of Information Act 2000.

Please note we aim to complete your internal review within 20 working days from the day following the date of receipt of your request. We will notify you if we anticipate the internal review taking longer than 20 working days.

FOI Team
Public Accountability Unit
Public Health England
[Public Health England request email]
www.gov.uk/phe Follow us on Twitter @PHE UK

dangos adrannau a ddyfynnir

FOI, Public Health England

1 Atodiad

OFFICIAL
Dear P. Newton,

Public Health England (PHE) has attached its response to your request for an internal review. As requested, within this response we have addressed your request to answer each question in turn, point by point.

Yours sincerely,
FOI Team

Public Accountability Unit
Public Health England
[Public Health England request email]
www.gov.uk/phe Follow us on Twitter @PHE UK

dangos adrannau a ddyfynnir