The Bio-Rad SARS-CoV-2 ddPCR Kit is a powerful diagnostic tool in the battle against COVID-19, with sensitivity and precision beyond that of qPCR assays.
The 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.
SARS-CoV-2 ddPCR Kit Components
To run the test, order the following components.
|12008202||2019-nCoV CDC ddPCR Triplex Probe Assay|
|1864021||One-Step RT-ddPCR Advanced Kit for Probes Supermix
|COV019||Exact Diagnostic SARS-CoV-2 Standard|
|COV000||Exact Diagnostic SARS-CoV-2 Negative|
|10000128901||SARS-CoV-2 ddPCR Test Instructions For Use|
Features and Benefits:
- 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
Additional materials required for running the QXDx AutoDG ddPCR System
|12001922||QXDx AutoDG Consumable Pack
|12002526||QXDx Droplet Reader Oil Pack||1|
|1863052||ddPCR Buffer Control for Probes||1|
Additional materials required for running the QX200 AutoDG ddPCR System
|1814040||ddPCR Pierceable Foil Seals||50|
|12001925||ddPCR 96 Well Plates||15|
|DG32 AutoDG Cartridges w/ Gaskets||15|
|Pipet Tips for AutoDG (Racks)||10|
|1864125||Waste Bins for AutoDG||N/A|
|1864110||AutoDG Oil for Probes||1|
|1863004||ddPCR Droplet Reader Oil||1|
|1863052||ddPCR Buffer Control for Probes||1|
Digital PCR Instruments & Software
Required to run the Bio-Rad SARS-CoV-2 Kit
|Catalog Number||Bundles or Different Instruments||Status|
|17002229||QXDx AutoDG ddPCR System, IVD system consisting of:||CE marked IVD System|
|17005351||QXDx AutoDG ddPCR System consisting of:||FDA-Cleared under K181661|
|1864100||QX200 AutoDG Droplet Digital PCR System consisting of:||RUO System|
|1851197||C1000 Touch Thermal Cycler with 96–Deep Well Reaction Module||RUO Lab Equipment|
|1852197||S1000 Thermal Cycler with 96–Deep Well Reaction Module||RUO Lab Equipment|
|1814000||PX1 PCR Plate Sealer||RUO Lab Equipment|
|All Systems use the following Software:
- Dong L. et al. Highly accurate and sensitive diagnostic detection of SARS-COV-2 by digital PCR. Medrxiv (Mar 2020).
- Liu Y. et al. Aerodynamic analysis of SARS-CoV-2 in two Wuhan hospitals. Nature (2020)
- Suo T. et al. ddPCR: A more sensitive and accurate tool for SARS-COV-2 detection in low viral load specimens. Medrxiv (Mar 2020)
- West C. et al. COVID-19 testing: The threat of false-negative results. Mayo Clin Proceedings
- Wang X. et al. Limits of detection of six approved RT-PCR kits for the novel sars-coronavirus-2 (SARS-COV-2). Clinical Chemistry (Apr 2020)
The US FDA has granted Emergency Use Authorization (EUA) for Bio-Rad's SARS-CoV-2 ddPCR Kit in the US.
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Pkg of 25, clear well/clear shell semi-skirted plates, for use with QX600/QX200 Droplet Digital™ PCR Systems
Pkg of 30, cartridges for use with the Automated Droplet Generator in the QX600/QX200 AutoDG Droplet Digital PCR System
Pkg of 60, cartridges for use with the Automated Droplet Generator in the QX600/QX200 AutoDG™ Droplet Digital™ PCR System
2 L (2 x 1 L), oil for use with droplet reader in the QX600/QX200 Droplet Digital™ PCR Systems
Pkg of 1, for use with QXDx Automated Droplet Generator, 480 reactions
1 L, for use with the QXDx ddPCR and QXDx AutoDG ddPCR Systems, 864 reactions
AutoDG Droplet Digital PCR System for EvaGreen or probe-based digital PCR applications, includes Automated Droplet Generator, QX200 Droplet Reader, computer, and QX Manager Software, Standard Edition.
Modular thermal cycler platform, includes C1000 Touch Thermal Cycler chassis, 96–deep well reaction module, USB flash drive