Day 2 and day 8 testing for international arrivals: minimum standards for providers (update)
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Contents Introduction Self-declaration Penalties and offences
Problems with test kits and results Minimum standards that apply to
day 2 and day 8 tests Introduction Testing requirements for when
you arrive in England from abroad depend on where you have been in
the 10 days before you arrive. The Red, amber and green list rules
for entering England lists countries and territories as either red,
amber or green...Request free trial
Contents
Introduction Testing requirements for when you arrive in England from abroad depend on where you have been in the 10 days before you arrive. The Red, amber and green list rules for entering England lists countries and territories as either red, amber or green and tells you what you must do if you have been in those countries or territories. Private providers may provide tests for day 2 and day 8 testing for international arrivals travelling from countries that are not on the red list. By law, all tests privately provided on day 2 and day 8 for international arrivals must meet minimum standards as outlined in the guidance below. The day 2 tests must be taken by all arrivals from green list and amber list countries. The day 8 tests must be taken by amber list arrivals who are not exempt from quarantine and day 8 tests. Read the full guidance to find out which amber list arrivals are exempt from quarantine and day 8 tests. International arrivals who have been in an amber list country and are not exempt from quarantine will still be able to opt in to Test to Release for international travel to shorten their quarantine period. Providers for Test to Release must meet separate minimum standards. Self-declaration Providers must also complete a declaration that their tests meet all of these standards. This self-declaration must only be completed by laboratories that will be conducting diagnostic test evaluation for mandatory coronavirus (COVID-19) testing for international arrivals. The laboratories completing the self-declaration will self-declare on behalf of themselves and all of the organisations they’re working with to provide these tests. They will need to list all organisations that they will be working with (whether by sub-contract or otherwise) in order to carry out this service. They will also need to list any organisations they will be working with (whether by sub-contract or otherwise) to carry out genomic sequencing. If you wish to change the list of organisations you are working with to provide the service and/or genomic sequencing, you will need to notify the Department of Health and Social Care (DHSC) of the nature of the arrangement and the name of this organisation. Penalties and offences If a private provider does not meet the standards required, they may be committing an offence and subject to a penalty. Problems with test kits and results Where a test kit is broken, is not delivered or gives an inconclusive or invalid test result, the provider should offer a replacement kit. Minimum standards that apply to day 2 and day 8 tests1. Requirement for a medical director and healthcare scientist The provider of the test must have a designated resourced role that has oversight and approval of medical practices undertaken by the provider and responsibility for reporting medical issues. The individual must be a registered medical practitioner ‒ registered with the General Medical Council. The provider must also have a designated resourced role that has oversight of clinical practices undertaken by the provider and responsibility for reporting clinical issues. The individual must be a registered medical practitioner or a healthcare scientist, registered with the Health and Care Professions Council. The same individual may fulfil both roles (medical and clinical), providing they are duly registered. 2. Requirement for effective system of clinical governance The provider of the test must have an effective system of clinical governance in place, which includes appropriate standard operating procedures in relation to the carrying out of the tests being provided for mandatory testing for international arrivals. For example:
3. The test device must be permitted to be put into service in accordance with part 4 of the Medical Devices Regulations 2002, other than solely by virtue of regulation 39(2) of those regulations. This requirement is to ensure that the testing device has a CE marking (or, following the UK’s exit from the European Union, a UK marking) and do not benefit from a derogation from those standards. A CE mark is a logo that is placed on in vitro diagnostic (IVD) medical device to show that it conforms to the requirements of the In Vitro Diagnostic Medical Devices Directive 98/79/EC. A CE mark shows that the testing device is fit for its intended purpose stated and meets legislative requirements relating to safety. From 1 January 2021, a test with a UKCA mark can be used. Tests with a CE mark can be used until July 2023. Further information is available on: 4. Reporting of coronavirus test results, as a notifiable disease The provider must have a system in place for reporting positive, negative and inconclusive test results cases in accordance with their obligations under public health legislation. All results of tests for this purpose must be reported within 24 hours of them becoming available. More information is available in Public Health England’s (PHE’s) guidance on the reporting of notifiable diseases. At booking, the provider (or sub-contractor, if relevant) must have a system in place to collect the following data fields from international arrivals:
Together with data required to be reported under public health legislation, the provider (or their subcontractor, if relevant) will need to have a system in place to collect from the international arrival and report the following additional data fields:
The following additional data must also be reported by the laboratory conducting genome sequencing:
Definitions of VOCs and VUIs can be found in the PHE variant guidance. All data reporting to PHE for day 2 and 8 testing for international arrivals must be conducted by the diagnostic laboratory, or sequencing laboratory where appropriate. 5. Reporting test sales You must complete a daily report that details your total sales to travellers arriving into England on the day of report completion. Test bundle sales should be reported by the traveller’s date of arrival in England. Providers must report whether tests sold are for green list, exempt amber list or non-exempt list arrivals. Test providers must also provide the test booking references for the sale completed on that day. This will need to be filled in by each customer facing provider that is selling tests directly to international arrivals. If you are a laboratory selling tests directly to the public, you will also be required to fill in the number of tests you have sold directly to international arrivals for this purpose and provide the test booking references. These reports will be required daily through a live form provided to testing providers who meet minimum standards. This information will not be used for any commercial purposes. 6. Relevant systems in place to report adverse test incidents The provider must be able to demonstrate that it has systems in place to identify any adverse incidents or quality control issues in respect of the test device and be able to report them in a timely manner to the relevant regulatory body. Medicines & Healthcare products Regulatory Agency (MHRA) has a dedicated coronavirus (COVID-19) yellow card portal to report adverse incidents with medicines, medical devices and diagnostics. 7. Use of age-appropriate test devices The test device should be age-appropriate, so it should be suitable to administer or provide a test to a person of the same age as the international arrival. 8. Sales of tests If the arrival has a job-related exemption and is staying in England for less than 8 days, private providers may supply them with a single day 2 test that meets the minimum standards. Genome sequencing must be included within the cost of any product that contains day 2 or day 8 testing. Private providers are able to sell a single day 2 test that meets minimum standards test for arrivals from green list or exempt amber list countries. Additionally, arrivals with a job-related exemption from quarantine who are staying in England for less than 8 days are only required to purchase a single day 2 test that meets the minimum standards. 9. Reference number format At the time the test bundle is booked, the test provider must provide a single test reference number to the person booking the test. If the provider sells multiple bundles to one person, each bundle will require its own booking reference. The booking reference must be in the required format. You should contact the private provider inbox for further information about the booking reference format. DHSC will issue the provider with a unique booking reference prefix for day 2 and day 8 testing during onboarding to the GOV.UK list. At the time of reporting test results to PHE, the laboratory must prefix their specimen number with the laboratory ID. Where laboratories go on to sequence the sample, they must use the same laboratory ID and specimen number as previously used to report the diagnostic test result, even if these 2 processes are performed by 2 separate laboratories. DHSC will issue the provider with a unique laboratory ID for day 2 and day 8 testing during onboarding to the GOV.UK list. 10. Issuance of booking reference From 6 April 2021, providers must only issue a booking reference to a customer once payment has been taken. 11. Sub-contractors or organisations you are working with If the test provider arranges with another provider or person (for example a sub-contractor) to carry out any element of the single end-to-end testing service on their behalf, the test provider must ensure that such person complies with the necessary requirements as relevant to the carrying out of that element of the service. This must result in the full end-to-end process meeting all of the relevant minimum standards. 12. Notification of test result: providers must issue the result of tests in a set notification which instructs the international arrival on whether they are required to quarantineForm A: negative test result Your coronavirus (COVID-19) test result is negative. You did not have the virus when the test was done. You are not required to quarantine if you are travelling from a green list country. If you are travelling from an amber list country, and are within the exempt category, you are not required to quarantine or take a day 8 test. If you are travelling from an amber list country and are not exempt, if you took the test on or before day 2 of your quarantine period, you must continue to quarantine until you have completed the 10 day quarantine and received a negative result for a test taken on day 8. If you took the test on day 8 you may stop quarantine when you have completed your 10-day quarantine period. You should self-isolate again if:
For advice on when you might need to self-isolate and what to do, go to www.nhs.uk/conditions/coronavirus-covid-19and read ‘Self-isolation and treating symptoms’. It’s a legal requirement to quarantine when you arrive in England. If you are contacted by the enforcement authorities or the police after you have received this negative result please show them this notification. Form B: positive test result Your coronavirus test result is positive. You had the virus when the test was done. Even if you have not had symptoms of coronavirus, you must self-isolate for 10 days from the day after your test date. Your test sample may be genome sequenced to check whether you have a virus variant of concern or variant under investigation. People you live with or are travelling with should also self-isolate for 10 days from the day after you took a test. If you received a positive test result for the test taken on or before day 2, you do not need to take the day 8 test. People you are travelling with must still take a day 8 test if they have travelled from an amber list country, unless they are exempt. You may be contacted for contact tracing and to check that you, and those who you live or are travelling with, are self-isolating. You must not travel, including to leave the UK, during self-isolation. Contact 111 if you need medical help. In an emergency dial 999. Form C: unclear test result Your coronavirus test result is unclear. It is not possible to say if you had the virus when the test was done. You must take another test or self-isolate for 10 days from the day after your test date. You may be contacted to check that you are self-isolating. 13. Compliant with all legal and regulatory requirements, for sample collection, processing and sharing of results including the requirements of data protection legislation The Information Commissioner’s Office (ICO) has set out FAQs on data collection and data protection relating to coronavirus (COVID-19) that provide further information, including GDPR considerations:
It is for you to satisfy yourself, taking legal advice as necessary, that you have met all the relevant legal and regulatory requirements relating to data protection. However, you will want to take full account of the fact that the processing of an individual’s health data is subject to additional levels of protection by Article 9 of the GDPR and can only be disclosed where it is necessary and proportionate for one of the specific purposes set out in that Article. You are also reminded that you run a risk of breaching Article 5 of the GDPRand the Data Protection Act 2018 and being subject to significant regulatory penalties if, having obtained health data from an individual under these standards, you:
14. Test kit delivery and administration Day 2 test kits must be delivered (or administered, where the provider is supplying a swabbing service) on or before day 2 of the traveller’s quarantine period. Day 8 self-swab test kits for non-exempt amber list arrivals may be sent out together with the day 2 test. However, the tests must be administered on or after day 8, including where swabbed by a test provider. 15. Turnaround time The provider should endeavour to provide test results within 48 hours of sampling. 16. Provider accreditation requirements
UKAS accreditation provides an assurance of the competence, impartiality and integrity of laboratories. This accreditation is an important element in establishing and maintaining confidence in a testing service. For polymerase chain reaction (PCR) or other lab-based testing, all samples must be processed by a UKAS accredited or applicant laboratory (the laboratory is accredited or has applied for UKAS accreditation but has not yet achieved it) and have quality management systems operating according to ISO 15189 or ISO/IEC 17025. Samples must also be taken by or under the written instruction of, a provider (and their sub-contractors, if relevant) that is applicant to ISO 15189 or ISO/IEC 17025. This requirement does not prevent issue of tests which are self-swabbed or self-administered since those samples would be taken under written instruction from the person responsible for taking the samples. UKAS appraisal status (‘stage 2’) became mandatory for commercial providers coronavirus (COVID-19) testing on 31 January 2021, or 4 weeks after they become a UKAS applicant and have self-declared on the gov.uk website confirming they meet minimum requirements. UKAS appraisal status is an assessment of compliance with the minimum requirements published by DHSC for fulfilment of stage 2. UKAS accreditation (‘stage 3’), which is full accreditation to the relevant ISO standard, will become mandatory for commercial coronavirus (COVID-19) testing by 1 July 2021, or 4 months after they have gained UKAS stage 2 appraisal status. 17. Use of tests that meet minimum performance characteristics The provider must use established molecular detection methods that have been independently validated by a laboratory with a UKAS accredited SARS-COV-2 RT-PCR method, or an ISO15189 or ISO/IEC 17025 accredited laboratory with the following performance characteristics as a minimum: For day 2 tests:
For day 8 tests:
Specifically, the assay must have been independently validated as having the required sensitivity and specificity using at least 150 positive clinical samples and 250 negative clinical samples against a laboratory-based RT-PCR test that is itself within the within the performance specification of the MHRA TPP for laboratory based SARS-COV-2 PCR tests. The viral load of the 150 positive samples should span the dynamic range of the assay in equal proportions (high, medium and low CT values). Independent validation must have been conducted, no more than 18 months before the test is provided, by one of:
Further guidance explaining how both virus and antibody tests work has been published by the MHRA. 18. Use of tests that are suitable for identification of SARS-COV-2 variantsThe assay must be semi quantitative and include a minimum of 2 distinguishable SARS-COV-2 gene targets not including S gene or performance reference controls. The assay should amplify more than 1 gene target in distinct regions and each gene target must be identifiable as a separate CT value or equivalent. Must include routine in silico assurance against variants of concern. The supplier should perform a minimum biweekly check of the amplification region and primer probes against new variants of concern reported by GISAID or PHE and report (within 48 hours) new variants that impact on the amplification target region, including primers, probs and amplicon. The test solution must provide extracted nucleic acid that is suitable for whole genome sequencing using a specified method.19. Targeted sequencing methods Sequencing shall be performed using a targeted sequencing method specific to SARS-CoV-2 or equivalent amplicon or sequence bait capture methods. An amplicon is defined as an amplified product of a PCR reaction. Sequence bait capture is a method for enriching a sample for a target of interest before sequencing using long single stranded nucleotide sequence ‘baits’ that bind to complementary sequence in the target. 20. Data provision to MHRA confirming variant sequencing capability The provider should ensure test manufacturers are providing data to the MHRA demonstrating the suitability of the device for identifying SARS-CoV-2 Variants of Concern. 21. Sequencing of samples with a <30 CT value All samples with cycle threshold (CT) values of <30 (defined as equivalent to ~10,000-1,000 viral genome copies/ml) must be sequenced. 22. Coverage of genome sequencing The percentage of target bases which should have been sequenced for a given number of times is set out below, as the coverage breadth:
23. Upload of BAM files For sequenced samples, the provider must report a sorted BAM file containing all reads aligning to the SARS-CoV-2 reference genome with unaligned reads removed and human reads removed. Upload of BAM files for sequenced samples will be required from 15 March. Further information will be provided on reporting BAM files to PHE shortly. 24. Preservation and transport of test material Provider must preserve and transport test material to support sequencing. Preferred Transfer of the original extract used for the PCR should be frozen at -20°C. The provider should maintain and evidence the storage conditions, including temperature logging. Acceptable Transport of sample from collection point to test site at 4°C using standard cold box systems in virus transport medium (VTM) within 6 hours. Use a standard flock or sponge swab designed for PCR. Purpose designed and validated swab and VTM kits should be used by test providers. More information is available. The courier should maintain and evidence the storage conditions, including temperature logging. 25. Removal of human reads Provider must have a process in place to remove human reads from any data submitted to a public repository. 26. Availability of samples for dual sequencing The provider must make samples available for dual sequencing on the request of NHS Test and Trace or the COVID-19 UK Genomics Consortium (COG-UK) and partake in assurance processes on request. 27. Turnaround time The provider should report the viral genome within 96 hours of sample collection and report the BAM file within 144 hours. 28. Requirement for a bioinformatician The provider should have a bioinformatician supervising genome sequencing. The same individual that fulfils the medical director and/or clinical oversight roles may also fulfil this role. |