Microbiologics, a provider of biological references materials, has launched its SARS-CoV-2 IVD control within its Helix Elite line of molecular controls, to help accelerate COVID-19 assay development and increase access to testing.
The new IVD product has been developed to provide quality control measures for the development, verification, and validation of diagnostic tests, offering precision and convenience of the Helix Elite line, said the company.
Microbiologics chief virologist Marylou Gibson said: “With all the unknowns of this new coronavirus strain, third party IVD controls with the right genomic targets are more critical than ever.
“This new SARS-CoV-2 control comes with the proven quality of the Helix EliteTM product line to assure your test results. 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.
“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.”
Helix Elite SARS-CoV-2 IVD control features large RNA molecule
The company said that its new SARS-CoV-2 Helix Elite control has been designed to work with the CDC-specified test components to generate positive PCR signals.
In addition, it features 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 Helix Elite SARS-CoV-2 IVD control has been manufactured to enhance the use and facilitate high-volume testing under ISO 13485 standards.
Furthermore, the company claimed that it is developing resources for the COVID-19, including IVD RNA controls with other gene sequences from the SARS-CoV-2 virus, to address the needs of researchers and diagnosticians.
The company is also offering additional coronavirus strains in live or inactivated formats, which include Human coronavirus OC43, Human coronavirus 229E, Human coronavirus NL63.
