Microbiologics, Inc. (Saint Cloud, MN, USA) has further expanded its comprehensive portfolio of SARS-CoV-2 molecular QC standards by launching IVD Process Controls and Inactivated Whole Virus Controls to meet the complex research and diagnostic challenges of the COVID-19 pandemic.

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, these 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. Lyophilized for stability and convenience, these controls can be shipped without dry ice.

“In the era of Emergency Use Authorization, quality control becomes more important than ever, putting everything to a critical test, in some cases even assay design, helping to remove flawed tests from the market,” said Aaron Fisk, VP of Microbiologics Virology Center. “Yet the diversity in gene targets and different collection processes have also made quality control more challenging than ever. These new controls provide broad, yet simplified QC solutions for SARS-CoV-2 testing.”

“The global response to COVID-19 depends on the accuracy and speed of testing,” Fisk stressed. “As the diagnostic landscape continues to change, these new SARS-CoV-2 controls provide some much-needed simplicity and confidence in the assays we depend upon test after test, day after day.”

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