COVID-19 Virology/Serology Surveillance

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RCGP RSC COVID-19 Virology & Serology Surveillance

Thank you for visiting our site. Participation in surveillance for virology and serology (detailed below), is open to practices registered with the RCGP RSC network. If you would like to register please complete this form: https://clininf.eu/index.php/recruit/
Serological surveillance for COVID-19

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). ID Sample serology for practices which do not have the above description.

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.
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  • 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.

Please click links to download information as needed:

  1. General serological surveillance lab form
  2. General serological surveillance patient information sheet
  3. Practice poster

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)
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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.

Virological surveillance for COVID-19

Overview

Patients who are triaged by phone consultation and are identified as having symptoms consistent with ILI, LRTI* AND/OR symptoms consistent with COVID-19.

*The RCGP RSC definition of influenza like illness (ILI) is:

An acute respiratory illness with a temperature measured/reported/plausibly ≥ 38 °C and cough, with onset within the past 10 days. ILI cases should not have another more plausible diagnosis.

ILI cases have a sudden onset, and there are often symptoms suggestive of systemic upset – myalgia, fatigue, malaise, headache etc.

Children under 5 years showing symptoms of acute bronchitis or bronchiolitis

Lower respiratory tract infection (LRTI) including pneumonia.

Surveillance protocol summary

  1. Patient contacts practice by phone and is identified as suitable for testing
  2. If agreeable, eligible patients are informed of the process
  3. The practice adds patient details to the testing kit
  4. Code the request (see below)
  5. Transport the testing kit to the patient (either by post to the patient or collected by a family or friend who is well (asymptomatic) and not living in the same household as the patient)
  6. When the result becomes available, code (see below) this into Clinical Medical Records and advise patient of results and complete clinical management if need

1. Patient population to be tested

Ask phone-triaged patients if they are happy to self-swab if they meet all of the following conditions:

  • Triage identifies patient with ILI, LRTI* AND/OR symptoms consistent with COVID-19
  • Initial patient contact was up to and including 7 days after symptom onset. Please note that while our definition of ILI is an onset of symptoms within 10 days, the lab tests are most accurate if sample is taken within 7 days.
  • No active management in a healthcare setting is required
  • Patient will have no difficulty in understanding instructions and if self-swabbing for a minor, parent/guardian is competent and confident in undertaking self-swab

If the patient is suspected of having COVID-19, and recorded by telephone consultation, code as:

Telephone consultation for suspected SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) 

If the patient is not eligible continue with normal management. If the patient meets criteria for ILI or LRTI, record the presenting problem as a diagnostic term not as a symptom or free text and complete relevant coding (see below) in the Clinical Medical Record System.

2. Contacting eligible patients

Contact patients according to practice procedures. This will usually be a call back by a healthcare professional or advise during initial triage phone call. If the patient is happy to self-swab for COVID-19, continue to step 3.

3. Adding patient details to the testing kit

 Open the flu template** in the Clinical Medical Record System and enter all relevant codes and complete ‘problem’ field as ILI and/or LRTI. Save, print this form, and place it into the kit.

 If you do not have access to the electronic flu template, please complete the E4 PHE Microbiology Request paper form that has been included in the self-swabbing kit. Place the completed form back into the kit AND enter all relevant codes and complete ‘problem’ field as ILI and/or LRTI.

 Please make sure that practice details and patient details including patient NHS number and DOB are complete on this form.

 When the request has been made please code:

Self-taken swab for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) offered

**If the flu swabbing template has not yet been downloaded, template installation instructions can be found at: https://clininf.eu/index.php/cov-19/

4. Coding the request

When the request has been made please code:

Self-taken swab for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) offered

Print and place a patient label in the kit for the patient to stick on the virology medium (SMALL green bottle) at home. Where this is not feasible please tell the patient to fill their details on the collection tube in clear, legible writing.

5. Advising the patient on testing and results

The patient should take the sample and have a well family or friend (not in same household) post it on the day they receive the kit and follow instructions to maintain good hygiene standards.  Please advise the patient that the results may take time as the virus is being monitored across the community and there may be a delay in receiving results. The patient should continue to follow advice on isolation.

6. Transport of the testing kit to the patient

Arrange for a self-sampling kit to be posted to the patient or collected by a well family or friend (asymptomatic) who is not living in the same household as the patient. Ensure that the completed paper form and printed patient label are placed with the kit before transfer to the patient.

The self-swab kit will include straight forward instructions. Once completed, the patient will have to package the completed self-swab in appropriate packaging supplied with a pre-paid addressed envelope, for testing. All materials and prepaid envelope are included in the self-swabbing kit.

7. Receiving a result and coding this into Clinical Medical Records

 Turn around of results may take up to 9-11 days if your chosen method or result delivery is by post. If you have registered with eLab this will be uploaded as soon as results are available.

When a swab result becomes available please code into the Clinical Medical Record system as follows:

Self-taken swab for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) completed

- If recording PCR test results of a positive case, code as:

SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) detected

- If recording PCR test results of a negative case, code as:

SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) not detected

OR if your clinical system does not recognise these SNOMED CT descriptions:

- If negative, code as:

COVID-19 excluded by laboratory test

- If positive, code as:

COVID-19 confirmed by laboratory test

Next steps

If a patient is confirmed to have COVID-19 by the PCR test they may be asked if they would be willing to provide blood after 28 days. If they have been chosen to do this, the RCGP RSC practice will be contacted in due course.

Please click links to download information as needed:

  1. General virological surveillance flow chart (v9)
  2. Word form: E4 PHE Microbiology Request Form

Virology kits

The kit consists of:

  1. UN3373 box
  2. Swab
  3. Noax secondary transport tube with absorbent
  4. Pre-paid addressed envelope
  5. Instruction on how to take the swab

The outer case contains:

  1. 20 kits as above
  2. 20 plain envelopes for dispatch to clients
  3. 20 forms coded to the GP practice
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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.

Further details

Protocol for ‘Emergence of a Novel Coronavirus (COVID-19): A Protocol for Extending Surveillance Used by the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) and Public Health England (PHE)’ can be viewed at:

https://publichealth.jmir.org/2020/2/e18606/

Ordering testing materials

Please order all kits and materials via this link:

https://clininf.eu/index.php/material-request/

FAQs

If you have any questions, please check our FAQs (https://clininf.eu/index.php/cov-19-surveillance-faqs),  prior to emailing practiceenquiries@phc.ox.ac.uk.

If your question has not been answered in the FAQs and is specific to:

  1. Coding or template, email lucy.moore@phc.ox.ac.uk
  2. Registration issues, practice keys or lab codes, email alexandra.deeks@phc.ox.ac.uk
  3. Principle trial, email manasa.tripathy@phc.ox.ac.uk
  4. General virological or serological surveillance, email vaishnavi.parimalanathan@phc.ox.ac.uk