SARS-CoV-2 Whole Virus & Full Process IVD Controls Join Microbiologics’ Extensive Line of Standards

September 10, 2020 |

3 min read

Offering a comprehensive portfolio of SARS-CoV-2 molecular QC standards, Microbiologics is launching IVD Process Controls and Inactivated Whole Virus Controls to meet the complex research and diagnostic challenges of the COVID-19 pandemic. “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 remov

Sept. 10, 2020 11:53 UTC

ST. CLOUD, Minn.--(BUSINESS WIRE)-- Offering a comprehensive portfolio of SARS-CoV-2 molecular QC standards, MicroBioLogics, Inc. is launching IVD Process Controls and Inactivated Whole Virus Controls to meet the complex research and diagnostic challenges of the COVID-19 pandemic. “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,” stated 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.”

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SARS-CoV-2. (Credit: Fusion Medical Animation Ltd.)

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.

These 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.

“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.”

These new controls join the most comprehensive line of SARS-CoV-2 QC and research materials in the world. To learn more about Microbiologics complete line of IVD and RUO solutions for SARS-CoV-2, visit www.microbiologics.com.

About Microbiologics: Microbiologics is the foremost biological products and services provider, focused on protecting the health and safety of people around the world. For nearly 50 years, they have been partnering with healthcare and life science laboratories, manufacturers and suppliers across the globe to co-create and provide biological control materials, assay services and consulting for microbiology, molecular diagnostics and virology. Headquartered in Saint Cloud, Minnesota, the company has additional facilities in Michigan, Kentucky and California. Microbiologics has advanced industry standards for biological controls by adopting the most rigorous testing and quality standards including ISO 13485, ISO/IEC 17025, and ISO 17034. The company has an extensive distribution network spanning over 150 countries. For more information, visit microbiologics.com.