Helix Elite™
Molecular Standards

 Positive Controls for Molecular Assays

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 three distinct formats for Helix Elite Molecular Standards – Inactivated, Synthetic Nucleic Acids and Genomic Extracts. Each format has been designed for efficiency and usability.

Here's a list of the top benefits our Helix Elite products provide:

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• 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

  • 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

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Applications and Test Methods

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• Sensitivity/Specificity

• Extraction/Amplification

• Presence/Absence

• Validation/Verification

• Proficiency/Training

• Assay Optimization

• Lot-to-Lot Testing