Microbiologics’ Helix Elite range provides a variety of biological reference materials that are used in both clinical and pharmaceutical laboratories as positive controls for various molecular assays. These controls are used for developing, validating, and monitoring molecular instruments and assays.
The Helix Elite range delivers positive controls with broad coverage of infections; including respiratory, gastrointestinal, STIs, blood culture ID and healthcare-associated infections (HCAIs). T
There are three distinct formats in the Helix Elite range – Inactivated, Synthetic Nucleic Acids and Genomic Extracts.
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.
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.
What benefits do Helix Elite products provide?
- Non-hazardous materials for safe handling.
- Ideal for pathogens which are difficult to grow.
- Optimized for time and labour savings.
- Independent external controls provide accurate, reliable results.
- Convenient room temperature storage.
- Compatible with a variety of instruments, kits and applications.
Helix Elite molecular standards can be supplied as individual controls or comprehensive control panels. For the complete list of Helix Elite molecular controls click here. Helix Elite molecular standards help support the development, validation, and monitoring of a broad range of laboratory-developed tests or commercial molecular assays. Let Microbiologics® help instil confidence in your test results by providing your lab with safe, simple and stable Helix Elite™ Molecular Standards!
Get in touch with our product specialist below who can help you find a control that is suitable for your specific testing requirements or browse our Microbiologics Molecular standards product range here