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
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.
Savings between $130-$175 per 96 well plate
Decrease in up to 50% of upfront sample processing
Decreases constraint in supply chain
Elimination of multiple manual steps may decrease potential errors
Reduces biohazardous plastic waste
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