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Microbiologics Introduces New IVD & RUO SARS-CoV-2 Controls

St Cloud, MN - Expanding upon its line of SARS-CoV-2 products, Microbiologics is launching two new products for quality control and research: an IVD control with pooled RNA gene targets and a RUO process control with the pooled gene targets encapsulated in protein, along with human respiratory epithelial cells.

IVD Control with the RdRp, S, E, and N Gene Targets


The new SARS-CoV-2 Helix Elite™ IVD control features a pool of diagnostically relevant large RNA molecules for the RdRp/Orf1ab, S, E, and N genes. These pooled genetic targets offer broad compatibility with CDC- and WHO-consensus sequences to generate positive PCR signals. This new IVD control comes with the proven simplicity and convenience of the Helix Elite™ line.

SARS-CoV-2 RNA Process Control (RUO)


In addition to the IVD Control, Microbiologics is introducing a new SARS-CoV-2 Process Control (RUO) with the diagnostically relevant protein encapsidated RNA sequences.

The RUO process control allows laboratories to validate all stages of a molecular assay, including extraction, reverse transcription, amplification, and detection. It is nuclease resistant and can be spiked into nuclease-rich patient samples, such as nasal secretions or plasma. The protein encapsulation functions like the virus’s protective envelope that sequesters and protects its RNA genome.

“The accuracy of diagnostic data continues to hamper the global response to COVID-19,” said Cynthia Forsman, Ph.D., molecular research and development scientist who led the project. “The availability of a full SARS-CoV-2 process control which closely mimics a true patient sample, while remaining noninfectious itself, is a critical step forward in the development and validation of COVID-19 assays.”

Featuring genomic targets for all seven WHO COVID-19 testing protocols, this RNA process control can be used for SARS-CoV-2 assay development, full process verification, and spike-in controls.

The RUO control contains human respiratory epithelial cells for assays designed to detect the presence of human cells as a means of ensuring adequate sample collection. The protective protein envelope and the complex matrix of human respiratory epithelial cells allow the process control to mimic a true patient sample. “The design and robustness of this control makes it amenable to a wide range of extraction, capture and molecular biology amplification technologies being used in the global response to COVID19,” stated Forsman.

Convenient Formats


The pooled IVD control is available as part of the Helix EliteTM (catalogue # HE0061S). The RUO process control is available as a pellet (catalogue # R9000) and a swab (catalogue # R9001). Shipped and stored at ambient temperature, these synthetic RNA controls are non-infectious and classified as BSL-1.

Partnering with Researchers & Manufacturers to Develop Resources for SARS-CoV-2


If you are an assay developer in need of unique controls for SARS-CoV-2, contact Microbiologics to discuss your quality control requirements.

Additional SARS-CoV-2 Quality Control & Research Resources


To view all Microbiologics SARS-CoV-2 IVD and RUO products that are available now and coming soon, visit https://www.microbiologics.com/sars-cov-2-quality-control.

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, Inc.