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First UKAS accreditations for COVID-19 diagnostic testing
The first accreditations for laboratories conducting COVID-19 diagnostic testing have been awarded.
The UK’s sole National Accreditation Body (UKAS) is responsible for the managing the accreditation assessments for all laboratories, in a process that is globally recognised. It has granted St Helen’s & Knowsley (STHK) NHS Trust accreditation against ISO 15189 (the medical laboratories standard), whilst the Metropolitan Police (Met) has been awarded accreditation to ISO/IEC 17025 (the general laboratories standard) . These accreditations are specifically for COVID-19 antigen testing and are the first to successfully come through UKAS’s new fast-track COVID-19 assessment process. STHK NHS Trust is using the accredited COVID-19 test for general patient diagnosis, whilst the Met’s accreditation covers the testing of its own staff to check if they currently have the disease.
The government, DHSC, PHE and NHSE/I have focussed on using UKAS accredited laboratories to deliver the increase in testing that has been required to date. UKAS continues to work closely with all the relevant stakeholders to help ensure effective and safe COVID-19 testing is expedited whilst maintaining the necessary levels of quality assurance.
Announcing the accreditations, Lorraine Turner Technical and Development Director at UKAS said: “Reliable testing is the cornerstone of the government’s pandemic strategy and UKAS has been working with all the relevant parties to achieve this. Ensuring there is nationwide confidence that a reliable testing regime exists is key to managing the disease and the potential easing of restrictions. UKAS accreditation underlines the competence of a laboratory to perform its scope of testing activities. This means that government, organisations and individuals who rely on testing can be confident in a quality outcome. We look forward to awarding accreditation to more laboratories for COVID-19 in the near future”
COVID-19 has required new test methods. With new tests, a separate process of assessment and validation is required before they are included in a laboratory’s scope of UKAS accreditation. Laboratories accredited by UKAS have proven they deliver quality management processes which ensure they consistently generate results which can be relied upon. The robust assessment covers both the testing activities and the quality process in recording and managing all samples. It also includes monitoring the output of test results. Whilst no test is 100% accurate, this process highlights any discrepancies in the test results that fall outside expected parameters in terms of false negatives or positives to ensure the precision of final results.
UKAS is currently assessing over 30 laboratories who have requested an extension to their scope of accreditation to include COVID-19 testing. These laboratories have applied for either COVID-19 antigen or antibody testing and operate across the public and private sectors. All laboratories are being assessed remotely in line with UKAS policy on social distancing, which will be in effect until at least 1st October 2020.