SARS-CoV-2 Droplet Digital PCR (ddPCR) Kit

SARS-CoV-2 Droplet Digital PCR (ddPCR) Kit

Overview

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.

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Description

Description

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.

Citations

  1. Dong L. et al. Highly accurate and sensitive diagnostic detection of SARS-COV-2 by digital PCR. Medrxiv (Mar 2020).
  2. Liu Y. et al. Aerodynamic analysis of SARS-CoV-2 in two Wuhan hospitals. Nature (2020)
  3. Suo T. et al. ddPCR: A more sensitive and accurate tool for SARS-COV-2 detection in low viral load specimens. Medrxiv (Mar 2020)
  4. West C. et al. COVID-19 testing: The threat of false-negative results. Mayo Clin Proceedings
  5. 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.

Ordering

Ordering

items

Use the filters below to refine results!

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(Discontinued) SARS-CoV-2 ddPCR Kit
12013743
600 tests, includes 2019-nCoV CDC ddPCR Triplex Assay, One-Step RT-ddPCR Supermix, reverse transcriptase, DTT, positive controls and negative controls

Other

Other

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1814040
Pkg of 100, foil seals for PCR and QX200/QX100 Droplet Digital PCR System applications, for use with PX1 PCR Plate Sealer
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dg32-automated-droplet-generator-cartridges-186-4008-thumb.jpg
1864108

Pkg of 30, cartridges for use with the Automated Droplet Generator in the QX600/QX200 AutoDG Droplet Digital PCR System

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dg32-automated-droplet-generator-cartridges-186-4009-thumb.jpg
1864109

Pkg of 60, cartridges for use with the Automated Droplet Generator in the QX600/QX200 AutoDG™ Droplet Digital™ PCR System

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pipet-tips-for-the-autodg-system-186-4120-thumb.jpg
1864120
Pkg of 20, boxes of 96 each, pipet tips for use with the Automated Droplet Generator in the QX200™ AutoDG™ Droplet Digital™ PCR System
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pipet-tips-for-the-autodg-system-186-4121-thumb.jpg
1864121
Pkg of 40, boxes of 96 each, pipet tips for use with the Automated Droplet Generator in the QX200™ AutoDG™ Droplet Digital™ PCR System
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pipet-waste-bins-for-the-auto-dg-system-186-4125-thumb.jpg
1864125
Pkg of 10, pipet tip waste bins for use with the Automated Droplet Generator in the QX200™ AutoDG™ Droplet Digital™ PCR System
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1864110
140 ml, oil for use with the Automated Droplet Generator for probe-based detection with the QX200 AutoDG Droplet Digital PCR System

Instruments

Instruments

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17005351
The FDA-cleared QXDx AutoDG Droplet Digital PCR System includes QXDx Automated Droplet Generator, QXDx Droplet Reader, QXDx Laptop Computer, and QXDx Software. The same FDA-cleared system can be used with the RUO software for probe-based ddPCR applications.
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1864100

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.

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1851197

Modular thermal cycler platform, includes C1000 Touch Thermal Cycler chassis, 96–deep well reaction module, USB flash drive

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1852197
Modular thermal cycler platform, includes S1000 thermal cycler chassis, 96–deep well reaction module
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PX1-PCR-Plate-Sealer-SKU-181-4000-thumb.jpg
(Discontinued) PX1 PCR Plate Sealer
1814000
PCR plate sealer, includes heat sealing instrument, plate support block that holds 96-well and 384-well plates, sealing frame, power cord

Download

Download

QuantaSoft™ Analysis Pro Software
QuantaSoft-Analysis-Pro-v1
QuantaSoft Analysis Pro Software, version 1.0, analysis tool for Droplet Digital™ PCR (ddPCR™)

Documents

Documents

Number Description Options
7377
Application of Droplet Digital PCR for SARS-CoV-2: Extraction-Free Process for Environmental Swabs
7372
Bio-Rad SARS-CoV-2 ddPCR Kit Flier, EUA IVD
7379
Bio-Rad SARS-CoV-2 ddPCR Kit Flier, RUO
7390
Application of Droplet Digital PCR for SARS-CoV-2: Extraction-Free Process for Nasopharyngeal Swab Specimens
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10000128583
SARS-CoV-2 ddPCR Kit Instructions for Use, EUA IVD
10000128901
SARS-CoV-2 ddPCR Kit, Instructions for Use, EUA IVD
10000130776
SARS-CoV-2 ddPCR Kit Instructions for Use, RUO
123-1071-EUA2004
SARS-CoV-2 ddPCR Kit Fact Sheet for Healthcare Providers
123-1072-EUA200440
SARS-CoV-2 ddPCR Kit Fact Sheet for Patients