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Advanced Biological Laboratories Gets CE Mark for SARS-CoV-2 qPCR Assay

NEW YORK ─ Advanced Biological Laboratories said on Monday that it has received CE-IVD marking for its UltraGene Combo2Screen SARS-CoV-2 qPCR assay, enabling its use in the European Union and other countries that accept the designation.

The Luxembourg-based firm said the qPCR detection kit has been validated with SARS-CoV-2 RNA extracted from nasopharyngeal swabs and saliva.

The assay targets two highly conserved regions of the SARS-CoV-2 genome ─ the nucleocapsid and envelope genes ─ in a multiplex format that includes an internal control, and it is compatible with most automated and manual RNA extraction methods and qPCR instruments, the firm said.

Testing that uses saliva as input may enable easier and broader population testing and screening, the firm said. Specifically, the use of saliva rather than traditional nasopharyngeal swabs improves the testing workflow and provides cost and convenience benefits.

The approach may also increase the acceptance of SARS-CoV-2 testing and enable the testing of asymptomatic patients, ABL said.