Bio-Rad - Model SARS-CoV-2 -Droplet Digital PCR (ddPCR) Kit

he Bio-Rad SARS-CoV-2 ddPCR Test is a partition based endpoint RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal anterior nasal and mid-turbinate nasal swab specimens, as well as nasopharyngeal wash/aspirate and nasal aspirate specimens from patients suspected of having COVID-19 by their healthcare provider.

The kit contains the 2019-nCoV CDC ddPCR Triplex Probe Assay, One-Step ddPCR Advanced Kit for Probes and SARS-CoV-2 positive and negative standards. These components are orderable individually now, and a single part number kit is in process.

The SARS-CoV-2 ddPCR Kit is optimized for use on Bio-Rad QX200 or QXDx AutoDG Droplet Digital PCR Systems. Analytic sensitivity is very high, calculated as 0.260 cp/µl to 0.351 cp/µl (cp = copies) for genetic markers, N1 and N2, using different extraction kits, without any significant loss in specificity.

Bio-Rad SARS-CoV-2 ddPCR Kit is intended for use by qualified clinical laboratory personnel specifically trained and instructed in ddPCR techniques and in vitro diagnostic procedures. Please see the Instructions for Use for additional information on the intended use of the test.

The US FDA has granted Emergency Use Authorization (EUA) for Bio-Rad`s SARS-CoV-2 ddPCR Kit in the US on May 1st, 2020.

• High sensitivity and precision in low viral abundance samples
• Easy-to-use software and systems
• Resistant to inhibition often seen in RT-PCR testing
• Single-well test — 3 sequences aligned to CDC markers: SARS-CoV-2 N1 and N2 genes, human RPP30 gene