Imegen: the first medical laboratory accredited to sample gold-nasopharyngeal exudate for SARS-CoV-2 analysis

Imegen: the first medical laboratory accredited to sample gold-nasopharyngeal exudate for SARS-CoV-2 analysis

2 March 2021 Industries

Imegen (Instituto de Medicina Genómica) has recently obtained accreditation from ENAC to perform the PCR test for detecting the SARS-CoV-2 virus and the gold-nasopharyngeal sample required for this analysis, thereby becoming the first clinical laboratory in Spain accredited for taking this sample.

In the words of Raquel Carrero, Imegen's head of Quality, "at the time the pandemic was declared, given society in general's lack of knowledge about the different tests for detecting the virus, we considered that it was essential to offer a service that generated the maximum confidence and reliability of the results". Both the correct obtaining of the oropharyngeal sample and its proper conservation and transport are essential for ensuring that it arrives with the required quality at the laboratory and that the results of the analyses are not affected.

"ENAC's accreditation generates this trust for several reasons: the test is accredited to an international standard (UNE EN-ISO 15189), that is to say, they are requirements interpreted in the same way regardless of the country where the laboratory is located. In addition, ENAC's accreditation implies the laboratory's technical competence for the accredited test, and this is critical, due to the situation of uncertainty that has been generated and the large number of laboratories that offer this type of test", says Raquel Carrero.

Accredited diagnostic services play a key role in ensuring that clinical decisions are made on the basis of reliable results and must therefore have the utmost technical competence. Accreditation according to the international standard UNE-EN ISO 15189 also provides benefits for both healthcare professionals and patients: “For professionals, it is synonymous with reliable results and clarity when interpreting the content of the report. For patients, it means putting themselves in the hands of a laboratory that has been recognized by an independent body as having the technical competence to perform the test”.

“We firmly believe - assures Imegen's head of Quality - that health authorities and local and national governments should require accreditation as an absolutely objective criterion which is synonymous with laboratories' competence and reliability when it comes to awarding and / or outsourcing these tests to the private sector. Unfortunately, this is not the case and Imegen will continue to fight and position for greater quality and transparency in these processes”.

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