All Year Virology and Serology Surveillance

Is surveillance on the NIHR Portfolio and is there an IRAS number?

Legal basis for surveillance is Health Protection defined in law in The Health Service (Control of Patient Information) Regulations 2002 - Regulation 3.

There is no official study number as surveillance is not research and therefore is not listed on the NIHR Portfolio.

How do I access the protocol?

Please view full protocol at: https://preprints.jmir.org/preprint/24341

When will the season officially start?

If you are currently taking part in general surveillance, please continue to swab and take blood samples. Please do not stop.

Until we are through the COVID-19 crisis there is no specific ‘season’; we will continue surveillance all year-round. We will be sending out new swabbing kits and 2020/21 E4 PHE Microbiology Request Forms from the last week of September. Voucher codes for TakeATest will be issued to practices on a weekly basis (Monday of each week). Number of voucher codes may vary each week.

We aim to commence this on Monday the 28^th of September.

What is the criteria for swabbing and blood sampling?

Please view flowchart for virology criteria.

For general serological surveillance, patients of all ages attending prescheduled blood tests are able to provide a sample.

Are there any significant changes from what we have done previously?

Voucher code system (TakeATest) will enable patients to request a self-swabbing kit direct to their homes. GPs will no longer need to post kits out to patients. (If eligible patients have attended a face-to-face appointment, practices can give patients a swab kit to self-test at home. Where appropriate, swabbing can take place in practices. Please follow PHE Guidances at all time.)
Symptom onset has increased from ‘up to 7 days’ to ‘up to10 days’
Swabbing kits will include nose and throat swabs
New (2020/21) E4 PHE Microbiology Request Form will be introduced
Patients will be asked to answer further questions online when requesting a self-swabbing kit

Do we have to participate in BOTH virology and serology?

No, you may choose to participate in either or both. Whilst we would like all types of practices, those with a high proportion of registered BAME patients are particularly welcome.

Do we have to choose between self-swabbing or face-to-face swabbing, or can we do a bit of both?

Please direct patients to the TakeATest website to request a self-swabbing kit. We suggest all practices have swab kits on their premises so that these can be handed out to patients who can self-swab at home. Where appropriate, we are happy for practices to take samples in practice. Please always follow PHE Guidance. (Remember to include the 2020/21 E4 PHE Microbiology Form if the practice is providing the swab kit.)

How will voucher codes be allocated?

Every Monday, practices will be emailed voucher codes to their allocated email address(es). If you have provided a primary and secondary email address, this will be emailed to both.

If a patient is happy to request a self-swabbing kit through TakeATest, what do we have to do?

Once informed verbal consent is obtained, please provide the following to the patient. This may be texted to the patient.

TakeATest webpage (https://takeatestuk.com/)
Unique voucher code
Patient’s NHS number
Short video for those needing assistance to request a self-swabbing kit

How will results be delivered?

Patients requesting a self-swabbing kit through TakeATest will receive their results as a text message. Those who receive a swab through their GP practice will need to be informed of results by their GP.

We would like to register with eLab to receive all our pathology results online. Who should we email?
Please email elab.Helpdesk@phe.gov.uk and include your practice name, practice code and postcode.

When will we receive the finalised flowchart? Where will this be updated if changes occur during the season?

Finalised flowchart and all other content will be updated on this webpage under ‘Virological surveillance’ by the last week of September.

Please continue to monitor this webpage for latest updates and information.

Where do I find patient instruction sheets and other useful links?

All materials will be added on this webpage (https://orchid.phc.ox.ac.uk/index.php/all-year-virology-and-serology-surveillance/) by the last week of September. Please click ‘Further information’ (below) to expand and view the latest information. Instructions and videos for patients are available at: https://takeatestuk.com/

Is patient information stored at the lab?

PHE does not store any clinical data with the samples. However, results are linked to pseudonymised clinical data. Studies are being carried out where often 1000s of serology results linked to clinical data are analysed. Most interest currently is how age, gender, ethnicity, household size, and population density link to rates of infection.

What is the reimbursement amounts for all year-round virology and serology surveillance?

Practices will be paid for all valid and complete samples per patient.

Virology – patients need to meet the criteria for a swab (please view flowchart).

Each virology sample will be paid at £7.50.

Serology - Practices will be paid per patient for complete sample(s). Blood bottle should be labelled clearly with all demographic details, lab form should be complete with patient and practice details, blood bottle should be inserted correctly and safely into secondary tube.

For complete samples practices will be paid:

£5.50 for >18 years of age

£11 for 8-17 years of age

£30 for <8 years of age

Are patients allowed a swab test for surveillance if they have already had a swab taken through Pillar 2 testing?

We ask that you prioritise patients who have not had a swab test. Swab test taken through Pillar 2 testing or through an alternate pathway does not preclude a patient from having a swab test for surveillance. We encourage you to swab as many patients as possible for surveillance.

What do we do with swabbing materials that were used for flu surveillance last year or more recently for COVID-19?

Component parts of any unused kits, prior to the delivery of new kits, should be returned. Please email practiceenquiries@phc.ox.ac.uk. We will then give you further instructions.

Please dispose all forms from the previous flu season and/or COVID-19 surveillance when you receive your new kits. Any VTM that requires refrigeration should be discarded into clinical waste.

Will Test and Trace be informed of positive results from patients who request a self-swabbing kit using the voucher code system (through TakeATest)?

Results are treated in the same way as other COVID-19 test results and so Test and Trace would be aware of positive results.

Virological surveillance

Aims
To monitor the spread of respiratory viruses (including influenza, COVID-19, RSV) and measure the effectiveness of influenza vaccinations through the winter season.

Design
Participating practices will provide swab/s from consenting patients suspected to be suffering or have recently suffered from flu or a similar respiratory illness. This can be done by either of the two pathways outlined below, depending on your practice workflow:

1) A self-testing kit can be delivered directly to the patient for the patient to self-swab at home. This will be an automated process whereby the patient will be given a voucher code to request a home kit via an online webpage for home delivery.

2) Practices can give patients a self-testing kit if they have attended a face-to-face appointment. If appropriate, a swab can be taken during a face-to-face consultation if the patient is already attending the practice. Please always follow PHE guidance.

The swabs will be stored and tested by PHE in order to set in context other measures of influenza surveillance in the population and assess population exposure and vaccine effectiveness. These samples will be tested for respiratory viruses and the results will be sent back to practices for follow up with the patient and for input of results into the patient medical record.

Please view the flowchart below for a detailed explanation of the process.

Serological surveillance

Aim
To assess background population immunity to COVID-19.

Design
Participating practices will collect an additional blood sample from patients attending a prescheduled blood test, following informed verbal consent.

Overview

Collection of an additional blood sample from patients with a prescheduled blood test.

Collecting blood samples from patients for serology surveillance is essential in order to assess background population immunity to COVID-19.

Please note, we will not be sending results back to the practice or patient.

Understanding of antibody response to COVID-19 is in its early stages and there is currently very little experience regarding use of antibody tests. This is applicable for both types of tests that are formatted as ELISAs (or laboratory tests) as well as for those that are formatted as Point-of-care-tests (POCTs). This subject has been discussed at the WHO within their specialist laboratory working groups. There is not enough evidence to enable a concrete understanding of relationship between detection of antibody (towards Sars-CoV-2) and the inferences about protective immunity offered by those antibodies. Hence it is not possible to give either antibody result or interpretation of antibody result for COVID-19 to practices or patients. The WHO link for more information: https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-point-of-care-immunodiagnostic-tests-for-covid-19

Key information to communicate to practice staff

The purpose of this study is to monitor background immunity to COVID-19 in the English population.
The risk of this study is low. One extra bottle of blood will be taken from the patient (when attending for a prescheduled blood test).
Only verbal consent is required from the patient, parent or guardian. The legal basis is Health Protection Regulation 3.
No results will come back to the practice or patient.
Please include Practice details and the patient’s NHS number, DOB and sex on the lab form.
Please code Save sample for serum serology (SNOMED CT ID: 509571000000108) in patient record (CMR). (If you require a Read code for your clinical system, please use: sample serology.)

Protocol summary for HCAs and phlebotomists

Please give patient the information sheet provided and ask if they are willing to consent to provide an additional blood sample. Only verbal consent is required for this.
Print your standard test request form with sticky labels (patient name, NHS number, DOB, sex) used by the practice. If you need to hand write it, please ensure writing is clear and legible.
Take an additional blood sample in the red top vacutainer provided.
Attach sticky labels (with patient details) to the additional blood sample (red top vacutainer) and place blood bottle into the white hard plastic container with green lid. Rubber stopper end outwards
Attach sticky label (with patient details) to this form and ensure practice name, NHS number, DOB, sex, and sample collection date are recorded.
Place the hard white plastic container with green lid with this form into the cardboard box (1 patient sample per box).
Place cardboard box into pre-labelled envelope.
Post it via standard post. Please do not put this sample in with any other pathology samples as this will NOT be going to your local trust lab. Please post on the same day.

Your package must include the following:

Red top vacutainer with sticky label (with patient details). This needs to go into white hard plastic container with green lid. Rubber stopper end outwards.
Green lid secondary tube then needs to be placed into the card board box with the completed lab form with sticky label (with patient details)
Place this into the provided prepaid envelope addressed:
FOR SEU USE ONLY
Vaccine Evaluation Unit
c/o Microbiology Reception
Floor 2 Clinical Sciences Building II
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
Remuneration

Practices will be paid per complete sample.

Please ensure: blood bottle is labelled clearly, lab form is complete with patient and practice details, blood bottle is stored in secondary tube correctly, correct coding is entered into CMR.
Thank you.

Serology kits

The kit consists of a small UN3373 transport box containing

1. BD Vacutainer 10.0 mL ref: 367895
2. Noax blood tube transport secondary with absorbent

(Box has the UN3373 diamond and proper shipping name on the top.)

Within the box are 25/50 sets of:

1. Information sheet for patients
2. Instructions for HCA/ phlebotomists
3. Prepaid envelopes (addressed to Vaccine Evaluation Unit)

All kits are checked twice over by the supplier before postage. Please empty out all contents of the large box and check thoroughly before emailing the PLO team.

We would like to sincerely thank all RCGP RSC practices for your dedication towards primary care surveillance during this challenging period.

Please click links to download information as needed:

- General serological surveillance lab form
- General serological surveillance patient information sheet (2020/21)
- Child Serology Certificate
  
  We have created a video guide to assist phlebotomists/HCAs below.

The new Serology dashboard can be accessed using your unique Practice Key. Please view a short guide on how to log in and track the number of samples you have already taken for serology here. We have been able to make this live for practices that have successful pseudonymised data extraction. If you have not received a link to your dashboard, your practice data is not live in our secure system. If you are happy to facilitate this and wish to view your dashboard(s), please get in touch.

Please provide feedback by emailing practiceenquiries@phc.ox.ac.uk