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Standards and guidance for private providers of COVID-19 testing

Pursuant to the Control of Testing (Jersey) Regulation 2020 (CoT Regs):

  • the Medical Officer for Health (MOH) is required to set and publish certain standards relating to the provision of COVID-19 testing services
  • providers of testing services must meet the standards published by the MOH from time to time
  • a health officer is, in certain circumstances, authorised to conduct certain inspections of the premises of any testing services provider to determine whether or not they are complying with the MOH set standards

The following sets out the standards for COVID-19 testing and guidance in reporting as determined by the Medical Officer for Health (MOH), under the CoT Regs.

It has been determined that all providers of COVID-19 Polymerase Chain Reaction (PCR) testing services premises will need to undergo an initial assessment and re-assessed annually on an ongoing basis.

Providers of PCR testing services must therefore provide Government of Jersey (GoJ) with certain details regarding their premises and the manner in which they provide such service.

Currently service providers who are only undertaking antigen lateral flow testing services or serology test services for COVID-19 antibodies do not need to provide such details to GoJ.

For more information related to COVID-19 PCR testing services email PCRApplication@gov.je

Different types of tests

These standards and guidance apply to all private providers offering any type of COVID-19 testing.

PCR tests: COVID-19 virus testing

PCR testing of respiratory tract samples is the recommended method for the identification and laboratory confirmation of COVID-19 cases.

A sample is taken which usually involves taking a swab of the inside the nose and the back of the throat. The sample is sent to a laboratory for analysis by a fully trained laboratory professional to check if coronavirus is present.

Laboratories that perform analysis of samples for COVID-19 PCR testing must be United Kingdom Accreditation Service (UKAS) ISO15159 or ISO17025 accredited for the performance of the COVID-19 PCR assay(s) they provide.

Antigen Lateral Flow Tests (LFTs): COVID-19 virus testing

Rapid antigen lateral flow tests help to find cases in people who may have no symptoms but are still infectious and can give the virus to others.

These tests may be administered by a healthcare provider or by self-administration.

The test usually involves taking a sample from the throat and nose, or from the nose only, using a swab. The test kit instructions will indicate how to complete the test.

Results are available in 10 to 30 minutes depending on the type of antigen LFT taken. The test kit instructions will indicate the time to wait before reading the result.

Serology tests: COVID-19 antibody testing

Serology tests detect the presence of antibodies in the blood. Antibodies to COVID-19 may be present because the individual has previously been infected with COVID-19 or because you have received a COVID-19 vaccine.

There are a number of laboratory tests which are CE marked and have been validated by Public Health England (PHE) as safe for use on blood drawn from the vein by a healthcare professional.

Some lateral flow devices have been developed to use a few blood drops to detect COVID-19 antibodies. None of these products have been validated by PHE and therefore should only be available for use by healthcare professionals, so that the results can be interpreted with the correct degree of caution.

More information on serology (antibody) tests on gov.uk

Standards for COVID-19 testing services

The following sets out the standards for COVID-19 testing and guidance in reporting as determined by the Medical Officer for Health (MOH), under the Control of Testing (Jersey) Regulation 2020 (CoT Regs).

These standards can be revised at any time by the MOH and take effect at the time of publication.

The standards are set out below.

1. Business Premises

For all premises at which a test is administered or analysed:

a. Standard Infection Control Precautions (SICPs) and Transmission-Based Precautions (TBPs) must be used

b. Training in Infection Prevention and Control (IPAC) measures should be provided to all staff, including the correct use of personal protective equipment (PPE).

c. Personal protective equipment must be worn by all personnel administering tests or working in areas where testing is taking place.

d. Hand-washing equipment must be provided (wash hand basins, liquid soap dispensers, disposable paper towels and pedal operated bins) in all areas where testing takes place.

e. Hand sanitizers must be available for the use of staff and clients.

f. Face masks must be available to clients and used by staff.

g. A private area should be available for the test to be administered.

h. Approved containers that are suitable for the type of waste generated must be provided. Waste audit data should be recorded and available for inspection.

i. Swabs and test kits must be stored as per the manufacturer's instructions

For more details see "UK Guidance - Infection prevention and control for seasonal respiratory infections in health and care settings including SARS-CoV-2 for winter 2021 to 2022.

2. COVID-19 testing providers

a. PCR testing services

All providers of COVID-19 PCR testing services must provide the Government of Jersey (GoJ) with the information it requires in relation to its provision of COVID-19 PCR testing services.

An on-site assessment will need to be completed and where a provider has passed such on-site assessment the Government of Jersey will issue the provider with a certificate confirming the same.  

For more information related to COVID-19 PCR testing services email PCRApplication@gov.je

Antigen lateral flow testing services

The Medicines and Healthcare product Regulatory Agency (MHRA) has approved several antigen Lateral Flow Tests (antigen LFT) for use in a supervised and home settings. The test must have a CE/UKCA mark.

The manufacturer's test kit instructions should be followed to reduce the risk of a false result.

Anyone interpreting any test results and advising clients, must be sufficiently clinically qualified to do so.

b. Serology (antibody) testing services

For any type of serology test, taking a blood sample, performing the test and interpreting results should only be undertaken by fully trained, healthcare professionals.

For serology Point of Care Tests (POCT) or Near Patient Tests, any devices should meet the requirements as set out in the Target Product Profile by the Medicines and Healthcare products Regulatory Agency (MHRA).

Anyone interpreting any test results and advising clients, must be sufficiently clinically qualified to do so.

3. Test results and reporting requirements

Any person who has taken a test must be given the result of that test accurately, and advised as to what action, if any, should be taken in accordance with relevant MOH or GoJ Public Health guidance.

All test results must be provided with sufficient information to enable the client to understand what the result means; this should take the form of written information wherever possible.

All reports given to clients should clearly show:

  • the client's forename and surname
  • date of birth
  • a unique medical number
  • date of sample
  • lab specimen number
  • date received by lab
  • date test performed
  • COVID-19 test method
  • COVID-19 test result
  • name of the lab providing result

Written advice regarding recommended actions following a test result (positive, negative or inconclusive) should be provided to the client.

All service providers must follow MOH guidance on how to exercise their duty to immediately notify the MOH of COVID-19 infection or how to seek advice where they have reasonable cause to suspect that a person is infected with COVID-19. (See section 4)

4. Positive test results and notifiable disease process

The Public Health Law places a duty on healthcare professionals and private individuals to report notifiable diseases.

If test results give rise to a reasonable suspicion that the person is infected with COVID-19, then the MOH should be notified.

The individual in receipt of the result is responsible for notifying the MOH of a positive case of COVID-19 via the standard Government of Jersey COVID-19 notifiable disease process, unless the test has been processed by the JGH Pathology laboratory, in which case the MOH will be automatically notified.

Below are three positive test results that may indicate that an individual is infected with COVID-19:

a. PCR positive test result

Any positive PCR test result from a UKAS COVID 19 test ISO15189 or ISO17025 accredited laboratory should be interpreted as confirmation of COVID-19 infection. 

b. Antigen LFT positive test result

A positive antigen LFT test result should be considered as likely evidence of current infection with COVID-19.

The individual should be advised to isolate and book a PCR test to confirm the positive result within 24 hours.

c. Serology IgM positive test result

Any serology test that shows a positive result for IgM antibodies, with or without positive IgG antibodies, should be considered as potential evidence of current infection with COVID-19.

The individual should be advised to isolate and book a PCR test to confirm the positive result within 24 hours.

Further advice on all test results can be obtained by phoning the COVID-19 helpline on 0800 735 5566

5. COVID-19 test kits

All test kits used for COVID-19 testing must have a CE/UKCA mark.

In order for a test to be safe to use, the company that develops this test must comply with the In Vitro Diagnostic Medical Devices Directive as implemented in the UK by Part IV of the Medical Devices Regulations 2002. Once they do, they are allowed to print a 'CE/UKCA' mark on their test. This CE/UKCA mark represents a declaration by the company that the test meets all of the legal criteria.

A 'CE/UKCA' mark is only valid if the following events happen in the way intended by the manufacturer:

  • collection of a sample (sometimes using a sampling kit).
  • testing of that sample.
  • reading and interpretation of results.
  • the provision of the result is accompanied by information to help you understand what they mean

Test kits are only reliable and a CE/UKCA mark valid if used in the way intended by the manufacturer. Therefore, where a service provider uses testing kits, everything comprised within those kits must be applied and processed in accordance with the testing kit manufacturer's instructions.

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