Microbiologics Introduces the First SARS-CoV-2 RNA IVD CE Marked Control

March 20  

Via Microbiologics

St Cloud, MN – To help accelerate COVID-19 assay development and increase access to testing, Microbiologics is launching a SARS-CoV-2 IVD control within its popular Helix EliteTM line of molecular controls. 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. 

“Since the outbreak of COVID-19, the complexity of testing methods has significantly impacted the quality of global data and our ability to monitor this virus,” Gibson stated. “The availability of recently-launched molecular assays and RNA controls for SARS-CoV-2 will dramatically improve our response to this global health crisis. The unsung heroes working in the diagnostics labs will need this level of quality control as the need for testing rapidly escalates.” 

Additional SARS-CoV-2 Quality Control & Research Resources 

Recognizing the complex needs of researchers and diagnosticians, Microbiologics is continuing to develop resources for the global response to COVID-19, including IVD RNA controls with other gene sequences from the SARS-CoV-2 virus (coming soon).  

For SARS-CoV-2 assay development, specificity validation, and other research needs, Microbiologics offers RUO synthetic SARS-CoV-2 RNA material (call 858-824-9000 or email [email protected] to order RUO material). 

Additional coronavirus strains are available in live or inactivated high titer formats: 

·        Human coronavirus OC43 

·        Human coronavirus 229E 

·        Human coronavirus NL63 

Microbiologics remains committed to continued innovation and delivery of products to meet the evolving needs of the research community. 

Please contact Microbiologics with your diagnostic or research requirements. 


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