Therapy Areas: Infectious Diseases
Microbiologics Adds SARS-CoV-2 Whole Virus and Full Process IVD Controls to Line of Standards
10 September 2020 - - US-based biological products and services provider Microbiologics is launching IVD Process Controls and Inactivated Whole Virus Controls to meet the complex research and diagnostic challenges of the COVID-19 pandemic, to add to its portfolio of SARS-CoV-2 molecular QC standards, the company said.

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.

These new controls join the most comprehensive line of SARS-CoV-2 QC and research materials in the world.

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 rigorous testing and quality standards including ISO 13485, ISO/IEC 17025, and ISO 17034.

The company has a distribution network spanning over 150 countries.
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