HDPCR™ SARS-COV-2 ASSAY

Announcing
Our New Direct Workflow**

New Direct Workflow: Up to 50% reduction in upfront hands-on-time and sample processing.**

Qualitative Real-time PCR assay that includes broad coverage of relevant variants.

Streamlined data management, error reduction, and simplified results interpretation with the ChromaCode Cloud™.

Test Benefits

  • Time and cost savings with the new direct workflow,** a self-contained internal control, and no extraction equipment required.
  • Frictionless adoption by utilizing existing qPCR instrumentation, 24-hour evaluation capability, and unparalleled customer support.
  • Full security and data privacy. HIPAA compliant cloud software that does not store protected health information (PHI).
  • Inclusive of CDC’s list of variants of concern and of interest

Variants Bulletin

Features of Direct Workflow**

Workflow steps

Automated Extraction Workflow

Direct Workflow††

Extraction Set-up

Pipette Steps: 8
HOT: 26 minutes
Total time: 53 minutes
Cost of consumables & reagents: $1.50-2.00/sample

Pipette Steps: 2
HOT: 5 minutes
Total time: 15 minutes
Cost of consumables & reagents: $0.10/sample

Extraction Time

27 minutes

10 minutes

Control

Spiked in during extraction. Potential for pipette error increasing chance of repeat.

Internal positive control included.

Reduce steps and decrease hands-on-time with our new Direct Workflow.

Interested in learning more about Transitioning from Pandemic to Endemic? Listen in as Blake W. Buchan, PhD, D(ABMM) and Pamela Ward, PhD discuss how labs can adapt to the changing SARS-CoV-2 testing landscape.

Key Test Specifications*

Direct Workflow**

Sample Type

Common upper respiratory samples

Automated Workflow

Sample Type

Common upper and lower respiratory samples

Extraction 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)

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)**

Control Type

Internal Positive Control

Control Type

Internal Positive Control

Turn-around-time

< 2.5 hours

Turn-around-time

< 3 hours

Scalable Throughput

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

Scalable Throughput

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

Storage/Stability

≤ -20 °C / 6 months

Storage/Stability

≤ -20 °C / 6 months

Resources

Request Additional Information

For Emergency Use Authorization Only | For in vitro diagnostic use | For prescription use only

*Compatibility is dependent on assay workflow. See IFU for details.

**Validation has not been reviewed by the FDA. Review under the EUA program is pending. This configuration is being distributed in accordance with the guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C