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

Microbiologics, Inc. (Saint Cloud, MN, USA) 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.

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. 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. Microbiologics offers their SARS-CoV-2 Whole Virus Antigen Control in a kit containing 6 individually packaged lyophilized swabs. Routine use of quality controls monitors test variation, lot-to-lot test kit performance, operator performance and aids in identifying random or systemic error.

“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. “We have confirmed the compatibility of our controls on multiple systems which allows users more flexibility.”

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