In relation to international travel into the UK, how does Test to Release and the new Day 2 & Day 8 international arrival testing work, and what part do two international standards play in the Government’s scheme? This blog post sets out the details.
The “red list” is the list of (currently) 7 countries from which travel to the UK is banned. You’ll be refused entry to the UK if you’ve been in any of these countries during the 10 days prior to arrival unless you’re the UK or Irish national or a third-country national with residence rights in the UK. As widely reported in the media, since 15 February, these individuals have been subject to a mandatory 10-day hotel quarantine. The red list countries are those where the incidence of the Covid-19 South African and Brazilian variants is believed to be high. They’re mainly in Africa and Latin America.
Meanwhile, anyone who arrives from a non-red list country must self-isolate for 10 days, but in England can potentially shorten their self-isolation by getting a negative Covid-19 test under the Test to Release scheme. Under the scheme, they must get their test from a government-listed eligible testing provider. Organizations can become listed as private providers of testing under the Test to Release (TTR) scheme and the Day 2 & Day 8 international arrival (Day 2 & Day 8 testing) scheme. It particularly focuses on the role of two key international standards.
The government wants to be sure that the providers of TTR and Day 2 & Day 8 services meet certain minimum requirements. These are set out in full on its website. But broadly, providers must first designate individuals with recognized registrations to act as their medical director and healthcare scientist. These roles can be filled by the same individual if they’re duly registered.
Providers must then have an effective system of clinical governance and must ensure that the testing devices used have a CE marking (or UKCA marking). In practice, from 1 January 2021 until July 2023, CE marking will be accepted.
For TTR, providers need to use established molecular detection methods that are at least 95% sensitive and at least 95% specific with a 95% 2-sided confidence interval entirely above 90%; and with a detection limit less than or equal to 1,000 SARS-CoV-2 copies per milliliter. These devices must be independently validated as such by a government scientific committee, or by an independent laboratory accredited to BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence or BS EN ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. More about these is below.
For Day 2 & Day 8 testing, minimum standards regarding assay performance are 99% sensitivity and 99% specificity with 95% confidence interval entirely above 97%.
Test devices must be age-appropriate. Providers must also have a system in place for reporting test results to PHE in accordance with public health legislation; plus they must demonstrate they can identify adverse incidents or quality control issues and report them in a timely manner to the relevant regulatory body.
Other requirements include that providers must supply a test reference number to the person booking the test; notify those tested of results within 24 hours; and give test results and other information to the police on request. Of most interest to us here, providers must be, and, a laboratory that has applied for; is being UKAS appraised for, or has already achieved UKAS accreditation for meeting the requirements of either BS EN ISO 15189:2012 or BS EN ISO/IEC 17025:2017. Organizations performing the sample collection only (sampling) must also apply for accreditation and become accredited by the end of June 2021.
BS EN ISO 15189:2012 sets out requirements that are specific to medical laboratories, sometimes called “clinical laboratories”. These are labs that are essential to patient care and must be available to meet the needs both of patients and clinical personnel looking after patients. The standard specifies requirements for the quality and competence of medical laboratories and is designed to ensure that they meet both the technical competence and management systems requirements necessary for them to deliver technically valid results consistently.
BS EN ISO/IEC 17025, meanwhile, specifies general requirements for the competence of laboratories and aims to promote confidence in how they operate. For the purposes of this standard, by the way, laboratories are defined as any entity performing testing, calibration, or sampling associated with subsequent testing or calibration.
The standard contains requirements that enable labs to demonstrate that they operate competently and generate valid results. It requires them to plan and implement actions that tackle risks and opportunities, thereby establishing a basis for increased effectiveness of their management system, improved results, and the prevention of negative effects. Labs are responsible for deciding which risks and opportunities should be addressed.
A final point to note is that if point of care testing (POCT) providers can demonstrate their molecular assay meets TTR minimum performance requirements, such providers) will need to comply with both BS EN ISO 15189:2012 and also with another international standard: BS EN ISO 22870:2016 Point-of-care testing (POCT). Requirements for quality and competence.