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Standards and guidance for private providers of COVID-19 testing

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 202 (CoT Regs).

Different types of tests

These standards and guidance apply to any private providers offering Molecular and/or Serology testing.

Molecular tests: COVID-19 virus testing

Molecular (for example, 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. In some cases, a saliva sample may be requested. The sample is sent to a laboratory for analysis by a fully trained, healthcare professional to check if coronavirus is present.

Serology tests: COVID-19 antibody testing

Serology tests detect the presence of antibodies in the blood of people believed to have been infected with COVID-19 in the past. 

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.

Other products called lateral flow devices have been developed to use a few blood drops applied to a small cassette in order 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.

The implications of a positive antibody test are as yet unknown. It is not clear if being infected in the past means a person is immune and they cannot get infected with coronavirus again in the future. It is also not clear whether it means a person can pass the virus onto others.

Standards for COVID-19 testing services

As per Regulation 2 of the CoT regs, the Medical Officer for Health sets the standards for the provision of COVID-19 testing services. Service providers must comply with these standards, or they will lose the element of their business licence that allows them to conduct COVID-19 testing.

The standards are set out below:

  1. for all premises at which a test is administered or analysed:
    1. standard infection control precautions (SICPs) and transmission based precautions (TBPs) must be used.  For more details see published guidance from Public Health England
    2. personal protective equipment must be worn by all personnel administering tests or working in areas where testing is taking place, as outlined in the Government of Jersey guidelines
    3. 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
    4. hand sanitizers must be available for the use of staff and patients
    5. approved containers that are suitable for the type of waste generated must be provided. Waste audit data to be recorded and available for inspection.
  2. all tests must have a CE 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' mark on their test. This CE mark represents a declaration by the company that the test meets all of the legal criteria.

    A 'CE' 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; and
    • the provision of the result is accompanied by information to help you understand what they mean
  3. as noted in standard 2, tests are only reliable and a CE 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. 
  4. no COVID-19 self-test kits have received a CE mark, therefore there are no self-test kits considered suitable for home use, and none should be supplied for use by members of the public. For clarity, a self-test kit involves taking a lay person taking a sample, testing that sample, and reading and interpreting the results by themselves
  5. for Polymerase chain reaction (PCR) testing, all samples must be processed by a UKAS accredited laboratory
  6. 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 and not by members of the public
  7. for serology Point of Care Tests (POCT) (An in vitro diagnostic medical device intended to be used by a healthcare professional outside of a laboratory in primary or secondary care environments) or Near Patient Tests (An in vitro diagnostic medical device that is not intended for self-testing but is intended to be used outside of a laboratory environment) intended to determine whether an individual has had the virus and is now immune, such devices should meet the requirements as set out in the Target Product Profile by the Medicines and Healthcare products Regulatory Agency (MHRA).
  8. anyone interpreting any test results and advising patients accordingly, must be sufficiently clinically qualified to do so
  9. any person who has undertaken 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 Government of Jersey Public health guidance
  10. all test results must be provided with sufficient information to enable the person to understand what the result means; this should take the form of written information wherever possible
  11. 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 on reporting below)

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

Reporting

The MOH must also publish guidance on reporting as per standard 11 above.

The Public Health Law places a duty on people that are not doctors to report notifiable diseases. In accordance with this law the following guidance is provided to assist people in determining:

  1. if the symptoms displayed give rise to a reasonable suspicion that the person is infected with COVID-19, and
  2. whether or not a person's test results give rise to a reasonable suspicion that the person is infected or contaminated with COVID-19

Symptoms of COVID-19

COVID-19 symptoms are a new continuous cough and/or fever which may be accompanied by one or more of the following:

  • headaches
  • tiredness
  • muscle ache
  • respiratory symptoms besides cough such as a sore throat, blocked or runny nose
  • gastro-intestinal symptoms can also be a feature of COVID-19 and these are more common in children than adults
  • loss of smell and taste (in some cases this may be the only symptom present)

Anyone experiencing any of the symptoms listed above, regardless of having a new continuous cough and / or fever, should be advised to self-isolate and call the COVID-19 helpline on +44 (0) 1534 445566. They will provide appropriate clinical advice and arrange diagnostic testing as appropriate. 

Test results indicting COVID-19 infection

PCR positive test result

Any positive PCR test result from a UKAS accredited laboratory should be interpreted as confirmation of COVID-19 infection. The healthcare professional in receipt of the result is responsible for notifying the MOH of a positive case via the standard Government of Jersey COVID-19 notifiable disease process.

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 patient should be advised to self-isolate and call the COVID-19 helpline on +44 (0) 1534 445566. They will provide appropriate clinical advice and arrange diagnostic testing as appropriate.

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