Armored Controls for Molecular Diagnostic Workflows
Asuragen, a Bio-Techne brand, provides robust, reliable molecular controls built on more than 20 years of product development and manufacturing expertise. Our Armored RNA®, Armored RNA Quant®, Armored DNA Quant™, plasmid DNA (circular and linearized), and in vitro transcribed RNA provide unique, target-specific solutions to meet all your molecular QC needs.
What is Armored RNA Quant Technology?
Armored RNA® technologies stabilize and protect nucleic acids from nuclease degradation by packaging them in a protective protein coat. Armored reagents deliver several end-user benefits, for an optimized workflow.
Watch the Video to Learn More About Stable, Non-Infectious, and Customizable Armored Control Process
- Available as catalog molecular controls or customized
- High-quality control solutions to monitor extraction and process efficiency
- Non-infectious, synthetic molecular constructs simplify shipping, handling, and storage
- Deployable as extractable, exogenous internal positive controls
- Degradation-resistant in majority of biological matrices
- Multiple configuration and custom manufacturing options available
- Available as cGMP controls and manufactured under an ISO 13485 quality system
- Validated targets and concentrations determined using metrological, traceable standards
- Highly standardized, quality-controlled manufacturing ensures reliability and consistency
Molecular Diagnostic OEM Services
Assay Development Through Global Commercialization
With a cGMP manufacturing facility governed by our ISO 13485 certified quality system, we can provide customized target Armored RNA and Armored DNA as well as custom multiplexed panels. Extensive quality control measures support products derived from any step of the manufacturing process, including plasmid DNA (circular or linearized) and in vitro transcribed RNA. Custom targets are available in three different grades: evaluation, development, and cGMP.
Delivering custom design, reliable service, and seamless integration for molecular diagnostic manufacturers
Molecular Assay Reagents
Our molecular assay reagents assist in various capacities, including sample transport, sample stability, and product development.
- TSM III is a buffered solution ideally suited for the dilution of Armored products. The additives provide stability to the protein-coated nucleic acid through multiple freeze-thaw cycles when stored properly, allowing for more flexible and scalable testing processes.
- RNARetain® is intended for the collection, storage, and transportation of fresh tissue specimens for subsequent RNA isolation and further molecular diagnostic testing. The collection of fresh tissue specimens into the RNARetain device eliminates the need to immediately process these specimens, enabling RNA extraction and molecular testing at a later time and/or transport to a different location.
A unique tumor bank of >100,000 clinical specimens.
The specimens span over 100 discrete cancer types across all major classes including melanoma, ovarian, breast, colon, and non-small-cell lung cancers. Our specimens are formalin-fixed, paraffin-embedded (FFPE) tissues, the majority of which are coupled with full histologic and demographic information.
Email Us About Our Tumor Bank Inventory
Armored RNA and Armored RNA Quant are registered trademarks and Armored DNA Quant is a trademark of Asuragen and Cenetron Diagnostics. RNARetain is a registered trademark of Asuragen.
*For Research Use Only. Not For Use in Diagnostic Procedures
Frequently Asked Questions
Ordering Molecular Quality Controls
- An average turn-around time for custom control delivery is 8-12 weeks.
- Timelines are dependent on project complexity and resource availability.
All molecular control products are shipped on dry ice unless another shipping format is specified by the customer.
We offer custom filling services for customers specified volumes per tube.
- Armored RNA - filled as-is or formulated to ≤ 0.25 mg/mL
- Armored RNA Quant/DNA Quant - can be formulated to any concentration equal to or below 1.0E+12 copies/mL
- Plasmid DNA - filled as-is or formulated to ≤ 0.1 mg/mL
- Linearized DNA - filled as-is or formulated to ≤ 0.1 mg/mL
- In vitro transcribed RNA - filled as-is or formulated to ≤ 2.0 mg/mL
- Customer-defined concentrations outside of these ranges will be considered
Molecular Quality Controls should be stored at the following temperatures:
- Armored RNA 2 to 8°C
- Armored RNA/DNA Quant -15 to -30°C
- Plasmid DNA -15 to -30°C
- Linearized DNA -15 to -30°C
- In vitro transcribed RNA -70 to -85°C
The following Molecular Quality Controls should be stored accordingly:
- Armored RNA - TSMIII storage buffer, available for purchase through Asuragen, a Bio-Techne brand
- Armored RNA/DNA Quant - TSMIII storage buffer, available for purchase through Asuragen, a Bio-Techne brand
- Plasmid DNA - TE (10mM Tris-HCl pH 8.0, 1 mM EDTA)
- Linearized DNA - TE (10mM Tris-HCl pH 8.0, 1 mM EDTA)
- In vitro Transcribed RNA - variable (sodium citrate, 0.1 mM EDTA, nuclease-free water, or as defined by the customer)
- Freeze-thaws should be kept to a minimum for all nucleic acid reagents.
- Armored reagents should not be subjected to more than five freeze thaw cycles.
- It is recommended to distribute into single-use aliquots upon receipt; we also offer custom aliquoting services to suit your laboratory workflow.
- Expiration dates are assigned only on molecular controls that have undergone appropriate stability studies.
- Representative Armored RNA Quant control products have demonstrated stability up to 3 years when stored at -15 to -30°C or 6 months when stored at 2 to 8°C after opening.
- No expiration date is applied to custom molecular controls unless specified by customer; it is the customer’s responsibility to apply expiration dating based on their own stability program.
- Incubation for at least 5 minutes at 75°C is sufficient to release the DNA/RNA from the protective pseudo-capsid for direct analysis. Armored reagents are compatible with most DNA/ RNA extraction methods.
- For samples with low nucleic acid content (e.g. blood plasma), addition of an RNA or DNA carrier is recommended to improve recovery of Armored RNA and Armored DNA.
- For extraction methods that include a white blood cell enrichment step, please ensure the Armored particles are added to the cell pellet before processing into lysate.
- Manufactured under ISO 13485 Quality System.
- Restricted laboratory access and laboratory gowning procedures.
- Physically and spatially segregated equipment and manufacturing processes.
- Dedicated Master Cell Banks.
- All open work performed in ISO Class 5 enclosures.
- Rigorous cleaning regimen: weekly, before and after material manipulation.
- GMP manufacturing available.
- Armored RNA - UV spectrophotometry
- Armored RNA/DNA Quant - analytical phosphate assay that utilizes a NIST-traceable standard
- Plasmid DNA - UV spectrophotometry
- Linearized DNA - UV spectrophotometry
- In vitro transcribed RNA - UV spectrophotometry
- Customer-defined quantification methods will be considered.
Please contact firstname.lastname@example.org for more information, we are happy to share the basic workflow of our process.
Armored RNA Quant SARS-CoV-2
The Armored process protects the RNA from degradation. This allows for its use as an extraction control as well as a process control. Additionally, the Armored capsid coat mimics viral coat proteins without being infectious, providing a safer alternative to live or inactivated virus controls.
Armored RNA Quant SARS-CoV-2 is an in vitro transcribed RNA encoding the SARS-CoV-2 viral nucleocapsid region that is encapsulated in phage coat protein particles. This sequence aligns with the CDC Diagnostic Panel N1/N2 and shares identity with at least 83 known isolates in the NCBI database.
Armored RNA Quant SARS-CoV-2 was originally designed against Wuhan isolate LR757998.1. The control sequence has 100% identity to 83 other isolates including Wuhan, Australia, USA, and Cruise.
It is a panel of in vitro transcribed RNA encoding the SARS-CoV-2 viral nucleocapsid, envelope, RNA- dependent RNA Polymerase, ORF1, and human RNase P regions that are encapsulated in phage coat protein particles.
This control contains multiplexed in vitro transcribed RNA encoding the SARS-CoV-2 viral nucleocapsid, Influenza, Respiratory Syncytial Virus, and RNase P regions encapsulated in phage coat protein particles. These sequence regions align with the US and China CDC and WHO recommended regions for SARS-CoV-2 testing.
Armored RNA SARS-CoV-2 controls are being used as positive reference controls for testing laboratories and inclusion in diagnostic kits.
It is an in vitro transcribed RNA encoding the RNase P gene that is encapsulated in phage coat protein particles. This sequence aligns with the CDC Diagnostic Panel recommendation.
The RNase P control is being used as an assay positive control to ensure test systems are behaving optimally.