2 days of virtual training on accreditation for SARS-CoV-2 virus identification

On request of the national accreditation bodies of the region, a 2-day virtual training was held on 9-10 February 2021 focusing on accreditation for SARS-CoV-2 virus identification.

The COVID-19 pandemic emerged the medical laboratories to provide tests for this virus and to demonstrate their competence by accreditation. The first day of the training was held for the personnel of the national accreditation bodies involved in the assessments (e.g. assessors, experts and file managers) and focused on the selection, verification, validation of examination procedures for identification of SARS-CoV-2 virus, while the second day was held for medical laboratories and focused on the PCR test and the serology tests. 

The training was provided by 2 experts, Aliki Stathopoulou and Ioannis Sitaras from the Hellenic Accreditation System (ESYD) and was moderated by Rózsa Ring.

There were 23 participants from 5 SEE countries in the first day when the trainers provided comprehensive interpretation of the 2 main groups of SARS-CoV-2 tests such as (i) tests detecting the presence of the virus itself (RNA and antigen tests), and (ii) tests detecting the immune response of the body against the SARS-CoV-2 virus, i.e. they report on past or ongoing infection with the virus (antibody tests). Besides the selection, verification and validation of these tests the participants could learn about how to ensure the quality of the examinations (internal quality control, external quality assurance and continuous quality improvement), the safety and efficiency of the examination services and the safe disposal of samples and medical wastes. There was a fruitful discussion on the SEE national accreditation bodies’ policies for accreditation for SARS-CoV-2 diagnostics, the related specific requirements and guidance documents and the availability of external quality assurance.

There were 39 participants from 4 SEE countries in the second day when first the nucleic acid amplification using the reverse transcription polymerase chain reaction (RT-PCR) as the most widely used method for direct SARS-CoV-2 diagnosis was presented, followed by the sampling methods (e.g. nasopharyngeal swab, etc.) illustrated by videos. Besides the PCR test, the trainers provided information on the serological tests and the interpretation of their results. Finally, the limitations of the SARS-CoV-2 tests, their applicability and fit-for-purpose were summarised. An Albanian medical laboratory shared its experiences related to PCR test (test methods, staff, premises, equipment, external quality assurance etc.). The national accreditation body of North Macedonia shared its policy related to accreditation of medical laboratories for SARS-CoV-2 diagnostics (specific requirements for laboratories, for the technical competence of assessors/experts, for external quality assurance etc.).There was a lively discussion on which standard (ISO 15189 or ISO/IEC 17025) should be implemented by a laboratory for SARS-CoV-2 virus identification, and the specificities of risk analysis for PCR test.

The feedback of the participants of both days of the virtual training was positive, they found the virtual training very informative and useful for supporting the medical laboratories and the assessment personnel of the national accreditation bodies to improve their activities related to the identification of SARS-CoV-2 virus or to extend their services.