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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 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:
- 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

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

- 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

Available products

Helix Elite™ Genomic Extract                    MBHE1156E        Acholeplasma laidlawii derived from NCTC 10116 Genomic DNA
Helix Elite™ Genomic Extract                    MBHE1180E        Mycoplasma arginini derived from NCTC 10129 Genomic DNA
Helix Elite™ Genomic Extract                    MBHE1176E        Mycoplasma fermentans derived from NCTC 10117 Genomic DNA
Helix Elite™ Genomic Extract                    MBHE1155E        Mycoplasma gallisepticum derived from NCTC 10115 Genomic DNA
Helix Elite™ Genomic Extract                    MBHE1157E        Mycoplasma hominis derived from NCTC 10111 Genomic DNA
Helix Elite™ Genomic Extract                    MBHE1178E        Mycoplasma hyorhinis derived from NCTC 10130 Genomic DNA
Helix Elite™ Genomic Extract                    MBHE1158E        Mycoplasma orale derived from NCTC 10112 Genomic DNA
Helix Elite™ Genomic Extract                    MBHE1177E        Mycoplasma pneumoniae derived from NCTC 10119 Genomic DNA
Helix Elite™ Inactivated Standard              MBHE0026N       Inactivated Adenovirus 2
Helix Elite™ Inactivated Standard              MBHE0034N       Inactivated Chlamydia pneumoniae
Helix Elite™ Inactivated Standard              MBHE0035N       Inactivated Chlamydia trachomatis
Helix Elite™ Inactivated Standard              MBHE0045N       Inactivated Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG)
Helix Elite™ Inactivated Standard              MBHE0040N       Inactivated Cytomegalovirus High Control
Helix Elite™ Inactivated Standard              MBHE0039N       Inactivated Cytomegalovirus Low Control
Helix Elite™ Inactivated Standard              MBHE0050N       Inactivated Enterovirus D68
Helix Elite™ Inactivated Standard              MBHE0036N       Inactivated Herpes Simplex Virus 1
Helix Elite™ Inactivated Standard              MBHE0037N       Inactivated Herpes Simplex Virus 2
Helix Elite™ Inactivated Standard              MBHE0029N       Inactivated Influenza A (H1N1) Virus
Helix Elite™ Inactivated Standard              MBHE0043N       Inactivated Influenza A (H3N2) Virus
Helix Elite™ Inactivated Standard              MBHE0044N       Inactivated Influenza A/B and Respiratory Syncytial Virus
Helix Elite™ Inactivated Standard              MBHE0030N       Inactivated Influenza B Virus
Helix Elite™ Inactivated Standard              MBHE0041N       Inactivated Neisseria gonorrhoeae
Helix Elite™ Inactivated Standard              MBHE0031N       Inactivated Parainfluenza Virus 1
Helix Elite™ Inactivated Standard              MBHE0032N       Inactivated Parainfluenza Virus 2
Helix Elite™ Inactivated Standard              MBHE0033N       Inactivated Parainfluenza Virus 3
Helix Elite™ Inactivated Standard              MBHE0028N       Inactivated Respiratory Syncytial Virus A
Helix Elite™ Inactivated Standard              MBHE0027N       Inactivated Rotavirus
Helix Elite™ Inactivated Standard              MBHE0042N       Inactivated Trichomonas vaginalis
Helix Elite™ Inactivated Standard              MBHE0038N       Inactivated Varicella Zoster Virus
Helix Elite™ Synthetic Standard  MBHE0001S        Cryptosporidium hominis Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0002S        Cryptosporidium parvum Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0025S        Cyclospora cayetanensis Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0015S        Dientamoeba fragilis Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0004S        Encephalitozoon intestinalis Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0007S        Entamoeba dispar Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0006S        Entamoeba histolytica Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0003S        Enterocytozoon bieneusi Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0016S        EXPORT LICENSE - Eastern Equine Encephalitis Virus Synthetic RNA
Helix Elite™ Synthetic Standard  MBHE0005S        Giardia lamblia Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0046S        Human papillomavirus 16 Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0048S        Human papillomavirus 18 Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0013S        Norovirus GI.1 Synthetic RNA
Helix Elite™ Synthetic Standard  MBHE0012S        Norovirus GII.4 Synthetic RNA
Helix Elite™ Synthetic Standard  MBHE0024S        Pan Mycoplasma Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0008S        Plasmodium falciparum Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0011S        Plasmodium malariae Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0010S        Plasmodium ovale Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0009S        Plasmodium vivax Synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0047S        Treponema pallidum synthetic DNA
Helix Elite™ Synthetic Standard  MBHE0014S        West Nile Virus Synthetic RNA