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Microbiologics Launches SARS-CoV-2 Whole Virus Antigen Controls for Point-of-Care COVID-19 Diagnostics

Saint Cloud, Minnesota, USA - Microbiologics has launched a new SARS-CoV-2 quality control (QC) product designed for use with antigen point-of-care (POC) methods. The inactivated SARS-CoV-2 Whole Virus Antigen Control is highly concentrated with fully intact genomic and viral proteins, making it suitable for both antigen tests and nucleic acid amplification tests (NAATs). It serves as a non-viable, external, positive control to evaluate the assay’s performance and mitigate the potential for false negative or false positive results. In NAAT applications, the control tests the full process including extraction, amplification and detection. In antigen-based applications, the high titer formula provides a clear positive reaction to monitor the detection of SARS-CoV-2 viral antigens.

Microbiologics is a global leader in microbiology and virology biomaterials for diagnostic technology development, drug development and quality control testing. Rapid POC antigen test methods for SARS-CoV-2 have become widely adopted during the COVID-19 pandemic due to capacity limitations and supply shortages for laboratory-based molecular methods. Antigen tests are also relatively inexpensive and provide a quicker time to result, making them ideal for instances where turnaround time is particularly critical, such as congregate housing settings and school health clinics.

“Our SARS-CoV-2 Whole Virus Antigen Control comes in a foam nasopharyngeal (NP) swab format similar to patient sample collection devices commonly used for COVID-19 testing,” shared Brian Beck, PhD., Microbiologics Vice President of Research and Development. Routine use of quality controls monitors test variation, lot-to-lot test kit performance, operator performance and aids in identifying random or systemic error. “We have confirmed the compatibility of our controls on multiple systems which allows users more flexibility,” Beck added. Microbiologics offers their SARS-CoV-2 Whole Virus Antigen Control in a kit containing 6 individually packaged lyophilized swabs.

Brad Goskowicz, Microbiologics Chief Executive Officer, commented, “Creating confidence is science is ingrained in who we are at Microbiologics. We’re incredibly proud to be supporting our partners on the frontlines in the fight against COVID-19 with biomaterials they can rely on to ensure the accuracy of their testing.”

The SARS-CoV-2 Whole Virus Antigen Control is the latest addition to Microbiologics’ extensive offering of In Vitro Diagnostic (IVD) quality controls and Research Use Only (RUO) materials designed to support the ongoing efforts to combat the COVID-19 pandemic. For more information about Microbiologics complete line of SARS-CoV-2 IVD and RUO solutions, visit 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 over 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.