Helix Elite™ Molecular Standards
Helix Elite Molecular Standards are used as controls for developing, validating, and monitoring molecular instruments and assays. These specialized biological controls support molecular technology developers and users in meeting regulatory requirements and providing confidence in their test. We offer two distinct formats for Helix Elite Molecular Standards – Inactivated and Synthetic Nucleic Acids. Both formats are designed for efficiency and usability. Here's a list of the top benefits our Helix Elite products provide:
- Non-hazardous materials for safe handling
- Ideal for pathogens which are difficult to grow
- Optimized for time and labor savings
- Independent external controls provide accurate, reliable results
- Convenient room temperature storage
Highlights
Inactivated Helix Elite Molecular Standards
- Fully intact, non-viable process controls
- FDA listed and CE Marked as an In-Vitro Diagnostic (IVD) Medical Device
- Used for every step of the molecular testing process, from extraction, to amplification and detection
- Quick dissolving lyophilized pellets may be reconstituted in buffer or transport medium
- Processed using the same protocols as the patient sample
Synthetic Helix Elite Molecular Standards
- Synthetic nucleic acid RNA and DNA sequences for use as amplification and detection controls in clinical assays
- Each standard contains consensus sequences of diagnostic regions from the target’s genome, representing the known genetic diversity of the microorganism; ready-to-use with no extraction required
- Compatible with a variety of instruments, kits and applications
Applications and Test Methods
- Sensitivity/Specificity
- Extraction/Amplification
- Presence/Absence
- Validation/Verification
- Proficiency/Training
- Assay Optimization
- Lot-to-Lot Testing
Package Details
Inactivated Helix Elite Molecular Standards
- Pellet format: 5 unassayed lyophilized microorganism pellets packaged in individual vials
- Swab format: 6 unassayed swabs containing an intact inactivated microorganism packaged in individual foil pouches
- Instructions for Use
- Certificate of Analysis
Synthetic Helix Elite Molecular Standards
- 1 vial of dried, stabilized RNA or DNA (approximately 100 reactions)
- 1 vial of molecular standard water for rehydration
- Instructions for Use
- Certificate of Analysis