Our partners Microbiologics have launched a SARS-CoV-2 IVD control within its popular Helix EliteTM line of molecular controls to help accelerate COVID-19 assay development and increase access to testing. This new IVD product provides quality control measures for the development, verification, and validation of diagnostic tests, with the unmatched precision and convenience of the Helix EliteTM line.
Featuring a large RNA molecule that matches the sequence of the virus N gene (which codes for the nucleocapsid phosphoprotein found in the shell of the virus), the SARS-CoV-2 Helix EliteTM control works with CDC-specified test components to generate positive PCR signals. “With all the unknowns of this new coronavirus strain, third party IVD controls with the right genomic targets are more critical than ever,” said Marylou Gibson, Microbiologics’ Chief Virologist. “This new SARS-CoV-2 control comes with the proven quality of the Helix EliteTM product line to assure your test results.”
Non-infectious and classified as BSL-1, the synthetic RNA control material is stable at room temperature to allow convenient shipping and storage. Manufactured under ISO 13485 standards, the Helix EliteTM SARS-CoV-2 IVD control is designed for extended use and flexibility to match the hectic pace of high-volume testing.
