'Test to Release' the new Government scheme

The UK Government is running a Test to Release scheme that allows certain international travellers to shorten the period of self-isolation they should observe when they first arrive in England. These are travellers arriving from countries other than those where the incidence of variant Covid-19 is known to be high.

Under the Test to Release scheme, the mandatory 10-day self-isolation can be reduced by getting a negative Covid-19 test from a provider on the Government’s list of eligible private testing providers.

To get onto that list, private providers of testing services must meet the Government’s minimum requirements. These include – among other measures – that they must be or use laboratories that have or are seeking UKAS accreditation to either 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.

Both documents set out requirements that, if met, confirm the quality, competence and impartiality of laboratories, ensuring that they consistently deliver technically valid results.

The standards

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.

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

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