Microbiologics SARS-CoV-2 whole virus and full process IVD controls

Microbiologics is launching IVD process controls and inactivated whole virus controls to meet the complex research and diagnostic challenges of the COVID-19 pandemic. The controls are designed to provide broad yet simplified QC solutions for SARS-CoV-2 testing.

The process controls and inactivated whole virus controls are available in ready-to-use swab and pellet formats that mimic patient samples to challenge every step of molecular testing, including sample collection and handling. Featuring a matrix of human epithelial lung cells, each control performs like a true sample within the nucleic assay procedure. By mimicking the patient sample format and performance, the controls challenge not only assays, but also processes and techniques.

The IVD controls each provide a complete validation for extraction, amplification and detection within a molecular assay. The inactivated whole virus controls contain the entire SARS-CoV-2 genome in a non-infectious state confirmed by a validated assay. The process controls provide diagnostically relevant gene sequences (Orf1ab/RdRP/S/E/ORF8/M/N gene regions) to match multiple diagnostic protocols. The synthetic RNA within the process controls is encapsulated in a phage protein envelope to validate the extraction process. Lyophilised for stability and convenience, the controls can be shipped without dry ice.