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

Alternative Extraction

HDPCRTM SARS-CoV-2 Direct

Extraction Set-up

Pipette Steps: 8
HOT: 26 minutes

Pipette Steps: 2
HOT: 15 minutes

Extraction Time

27 minutes

10 minutes

Total Time

53 minutes

25 minutes

Control

Spiked in during extraction.

Internal positive control included.

Cost of Consumables & reagents

$1.50-2.00/sample

$0.10/sample

Blake W Buchan, PhD, D(ABMM), Derek Gerstbrein, Amorina Cruz, Jess Hoff, PhD, Emily Sievert, Nathan A Ledeboer, PhD, D(ABMM), Matthew L Faron, PhD, Evaluation of a High-Definition PCR Assay for the Detection of SARS-CoV-2 in Extracted and Nonextracted Respiratory Specimens Collected in Various Transport Media, American Journal of Clinical Pathology, 2021.

Review under the EUA program is pending. This is being distributed in accordance with the guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.

i1

Savings between $130-$175 per 96 well plate

i2

Decrease in up to 50% of upfront sample processing

i3

Decreases constraint in supply chain

i4

Elimination of multiple manual steps may decrease potential errors

i5

Reduces biohazardous plastic waste

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Decrease expense in extraction consumables

Direct Workflow. Direct Savings.

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

CAP Today Webinar. June 15, 2021

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

Direct Workflow**

Sample Type

Common upper respiratory samples

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

Turn-around-time

< 2.5 hours

Scalable Throughput

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

Storage/Stability

≤ -20 °C / 6 months

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)**

Control Type

Internal Positive Control

Turn-around-time

< 3 hours

Scalable Throughput

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

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