HDPCR™ SARS-COV-2 ASSAY*

For further information see below

For Emergency Use Authorization Only

For in vitro diagnostic use

For prescription use only

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Qualitative Real-time PCR assay that combines CDC recommended testing into a single test

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SARS-CoV-2 testing is in high demand during these unprecedented times

Help combat further spread with an assay that increases test throughput and simplifies results interpretation for laboratories

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A table containing information on hdpcr sars-cov-2 assay and covid-19 information.

> Increase throughput and decrease time to identification by testing the consolidated CDC assay in a single test

> Seamless integration & cost effective by utilizing existing qPCR instrumentation and standard workflow

> Streamline data analysis using cloud-based software

> Full security and data privacy. HIPAA compliant cloud software that does not store protected health information (PHI).

> Inclusive of the following variants:

The United Kingdom Variant, known as 20I/501.V1, VOC 202012/01 or B.1.1.7
The South African Variant, known as 20H/501.Y.V2 or B.1.351
The Brazil/Japan variant, known as 20J/501Y.V3 or P.1
The Denmark/California Variant known as L452R

See Resources for full bulletin or Instructions for Use for updated inclusivity

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Key Test Specifications

Sample Type

Common upper and lower respiratory samples*

Instrument Compatibility

Roche MagNA Pure 24 System
Thermo Scientific™ Kingfisher™ Flex Purification System

qPCR Instruments Compatibility

Applied Biosystems™ 7500 Fast
Applied Biosystems™ 7500 Fast Dx**
Applied Biosystems QuantStudio™ 5 (96-well, 0.2mL and 384-well)**
Applied Biosystems QuantStudio™ 7 (96-well Fast and 384-well)**
Applied Biosystems QuantStudio™ 12K Flex (96-well Fast and 384-well)**

Run Time

< 1.5 Hours

Throughput

Scalable: 1-88 samples/96-well plate or 1-373 samples/384-well plate

Storage/Stability

≤ -20 °C / 6 months

Resources

View Ordering Information*See IFU for details

** Validation of Applied Biosystems™ 7500 Fast Dx, QuantStudio™ 5 (96-well, 0.2mL and 384-well), QuantStudio™ 7 (384-well), and QuantStudio 12K Flex (384-well) have not been reviewed by FDA. Review under the EUA program is pending.

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