Purchase of Bio-Rad OPUS Dx instruments for detection of influenza and SARS-CoV-2 from clinical specimens.

Procurement Summary

This is a sole source requirement for Bio-Rad’s OPUS DX instruments required to detect influenza and SARS-CoV-2 from clinical specimens. The instrument is FDA-approved (IVD-cleared) rRT-PCR that can be used in conjunction with the CDC FDA-approved and FDA-authorized in vitro diagnostics for detection of Influenza and SARS-CoV-2 viruses from clinical samples. This instrument uses a distinct method for collecting the data in each well that is unique to BioRad instruments. Furthermore, Bio-Rad’s OPUS DX uses a 96-well block with a scanning method for data collection. It can multiplex up to 5 targets, allowing the CDC to adapt FDA-approved and authorized IVD and EUA diagnostics for influenza and SARS-CoV-2 to run on this instrument. BioRad will manufacture supplies and provide services to the BioRad OPUS Dx. The government is specifically purchasing the BioRad OPUS rRT-PCR system to evaluate the performance of our FDA-cleared and FDA-approved in vitro diagnostic assays for influenza and SARS-CoV-2 on this instrument.

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