Accredia / Tests / Coronavirus, the first laboratories for research of the virus in swabs obtain accreditation

Coronavirus, the first laboratories for research of the virus in swabs obtain accreditation

16 February 2021

The accreditation of medical testing and analysis laboratories according to international standards strengthens the tools to combat the Covid-19 pandemic. Accreditation has been obtained in Italy, in Padova and Teramo, and the European Commission recognizes its value.

The Laboratory of Microbiology and Virology of University Hospital of Padova, led by prof. Andrea Crisanti and the Laboratory of the Experimental Zooprophylactic Institute of Abruzzo and Molise, in Teramo, are the first laboratories accredited by Accredia for the research of Coronavirus in throat swabs. This is another important contribution of Accredia to the fight against the pandemic due to Covid-19.

The laboratories had to demonstrate that the test procedure conducted on the swab has suitable performance in terms of sensitivity, specificity, repeatability and limit of determination, by undergoing the assessment tests conducted by Accredia’s assessors, aimed at ascertaining competence, independence and the impartiality of the way the structures operate.

“Accreditation represents an additional guarantee both for the health of citizens, who can thus count on tests carried out with competence and reliability, and for the laboratory itself, which achieves a real rise in quality in terms of greater reputation” explained the President of Accredia, Giuseppe Rossi. “Thanks to the activities carried out by Accredia, Government Authorities can rationalize and simplify the controls on the health facilities that provide these services”, continued Mr. Rossi. “It is for this reason that both at the national level, as happens in the Autonomous Province of Trento, and at European level, as in France, the accreditation of medical laboratories according to the ISO 15189 standard is a mandatory requirement”.

Accreditation obtained by the laboratories provides for the verification, both in terms of conformity of the management system and the technical adequacy of the laboratory, of all the processes involved in research of the SARS-CoV-2 virus, with particular reference to the competence of the staff, validation of the diagnostic system used, sampling and transport, work areas, equipment, metrological traceability, quality assurance, interpretation and presentation of the results of the tests.

The European Commission has also recently expressed its opinion on the value of accreditation, with the Recommendation 2020/1743 of 18 November 2020, which invites Member States to use ISO 15189 accredited medical laboratories for the diagnosis of SARS-CoV-2 infection, because these laboratories, the Recommendation reads, “meet high quality requirements” and because accreditation guarantees that the laboratories “are subjected to periodic checks and meet the necessary quality and competence requirements“.

“We hope that in Italy, already a leading country in laboratory medicine”, concluded Mr. Rossi, “there may be other structures that choose the path of accreditation”.