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
Genomic Extract Helix Elite Molecular Standards
- Used as a positive control for the amplification and detection steps in molecular assays
- Dried, stabilized and quantitated nucleic acid extracted from target pathogens
- Each preparation is assessed for purity, integrity and provided with a gene copy number for quantitation.
- Cost effective, reliable results; no extraction required
- Sensitivity/Specificity
- Extraction/Amplification
- Presence/Absence
- Validation/Verification
- Proficiency/Training
- Assay Optimization
- Lot-to-Lot Testing
Inactivated Helix Elite Molecular Standards
- 5 unassayed lyophilized microorganism pellets packaged in individual vials
- 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
Genomic Extract Helix Elite Molecular Standards
- 1 vial with at least 106 copies of Genomic DNA
- Helix Elite™ Molecular Standard Water for rehydration
- Instructions for Use
- Certificate of Analysis
