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Helix Elite™ Synthetic DNA/RNA

Helix Elite™ Molecular Standards are specifically designed and synthetically produced nucleic acids for use as a genetic surrogate for pathogens that are difficult to grow or that require specialized facilities or staff. Each standard contains consensus sequences of diagnostic regions from the target’s genome and represents the known genetic diversity of the microorganism.

These molecular standards support the development, validation, and monitoring of a broad range of laboratory developed tests or commercial molecular assays. Rely on Microbiologics® as your source for safe, simple and stable Helix Elite™ Molecular Standards and increase confidence in your assay!

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Methicillin-Susceptible Staphylococcus epidermidis (MSSE) Inactivated
Artikelkod HE0055NS


Each kit includes six individually packaged swabs containing Methicillin-Susceptible Staphylococcus epidermidis (MSSE) and a Certificate of Analysis.

Biosafety Level 1
Product FormatHelix Elite™ Inactivated Standard
Catalog numberHE0055NS
Permits and RestrictionsExport Restrictions May Apply
TaxonomyBacteria
Industry TypeClinical

Human Papillomavirus 16 (HPV 16) Cellularity Control (Inactivated Pell
Artikelkod HE0056N

Inactivated Helix Elite Molecular Standards are specially designed, full process controls for use in molecular testing. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.

Biosafety Level 1
Product FormatHelix Elite™ Inactivated Standard
Catalog numberHE0056N
Industry TypeClinical

Human Papillomavirus 18 (HPV 18) Cellularity Control (Inactivated Pell
Artikelkod HE0057N

Inactivated Helix Elite Molecular Standards are specially designed, full process controls for use in molecular testing. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.

Biosafety Level 1
Product FormatHelix Elite™ Inactivated Standard
Catalog numberHE0057N
Industry TypeClinical

Negative Cellularity Control (Inactivated Pellet)
Artikelkod HE0058N

Inactivated Helix Elite Molecular Standards are specially designed, full process controls for use in molecular testing. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.

Each pellet contains A549 lung epithelial cells

Biosafety Level 1
Product FormatHelix Elite™ Inactivated Standard
Strain CharacteristicsEach pellet contains A549 lung epithelial cells
Catalog numberHE0058N
Industry TypeClinical

SARS-CoV-2 Synthetic RNA (N Gene Targets)
Artikelkod HE0060S


Synthetic RNA molecular standard intended for use as a positive control in molecular applications. Kit includes: 1 vial of dried synthetic RNA (up to 100 reactions), 1 vial of molecular standard water for rehydration and a Certificate of Analysis.

Biosafety Level 1
Product FormatHelix Elite™ Synthetic Standard
Strain CharacteristicsThe SARS-CoV-2 synthetic RNA material is a 1044-nucleotide portion of the SARS-CoV-2 N (nucleocapsid) gene. It contains three markers N1, N2 and N3 that are commonly used in diagnostic assays.

Dried RNA Preserved with Biomatrica RNAstable®

IVD
Catalog numberHE0060S
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

SARS-CoV-2 Synthetic RNA (N/E/RdRp/S Gene Targets) (Pellet)
Artikelkod HE0061S


Synthetic RNA molecular standard intended for use as a positive control in molecular applications. Kit includes: 1 vial of dried synthetic RNA (up to 100 reactions), 1 vial of molecular standard water for rehydration and a Certificate of Analysis.

Biosafety Level 1
Product FormatHelix Elite™ Synthetic Standard
Strain CharacteristicsThe SARS-CoV-2 synthetic RNA material is a pool containing the following genetic targets:
• N gene (position 28237-29280) which contains three markers N1, N2 and N3 that are commonly used in diagnostic assays
• E gene (position 26245-26472)
• RdRp gene (positions 12641-12824, 13442- 16236)
• S gene (position 21563-25384)

All positions in reference to GenBank Acc. NC_045512.2

Dried RNA Preserved with Biomatrica RNAstable®

IVD
Catalog numberHE0061S
TaxonomyViruses
Industry TypeClinical

Inactivated SARS-CoV-2 Whole Virus (Pellet)
Artikelkod HE0065N

SARS-CoV-2 Whole Virus can be used to monitor the extraction, amplification and detection of SARS-CoV-2 molecular applications. Routine use of external quality controls monitor day to day performance of molecular testing procedures. Each kit contains 5 individually packaged lyophilized pellets and 5 vials of molecular standard water for rehydration.

 

Biosafety Level1
Product FormatHelix Elite™ Inactivated Standard
Strain CharacteristicsThe Inactivated SARS-CoV-2 Whole Virus (Pellet) is made with whole inactivated SARS-CoV-2 virus (Isolate SARS-CoV-2/USA/WA1/2020) and inactivated A549 lung epithelial cells.
Test MethodMolecular Testing
Catalog numberHE0065N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated SARS-CoV-2 Whole Virus (Swab)
Artikelkod HE0066NS

SARS-CoV-2 Whole Virus can be used to monitor the extraction, amplification and detection of SARS-CoV-2 molecular applications. Routine use of external quality controls monitor day to day performance of molecular testing procedures. Each kit contains 6 individually packaged lyophilized swabs.

 

Biosafety Level2
Product FormatHelix Elite™ Inactivated Standard
Strain CharacteristicsThe Inactivated SARS-CoV-2 Whole Virus (Swab) is made with whole inactivated SARS-CoV-2 virus (Isolate SARS-CoV-2/USA/WA1/2020) and inactivated A549 lung epithelial cells.
Test MethodMolecular Testing
Catalog numberHE0066NS
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Negative Cellularity Control (Inactivated Swab)
Artikelkod HE0067NS

Negative Cellularity Control (Inactivated Swab)

Inactivated Helix Elite Molecular Standards are specially designed, full process controls for use in molecular testing. Each kit consists of 6 individually packaged lyophilized swabs that contain human lung epithelial cells.

RUO SARS-CoV-2 Process Control (Pellet)
Artikelkod R9000

SARS-CoV-2 Process Control can be used for SARS-CoV-2 assay development, full process control (including extraction), sample adequacy control and spike-in controls. Each kit contains 6 individually packaged lyophilized pellets.

Biosafety Level: 1
Product Format: Helix Elite™ Synthetic Standard
Strain Characteristics: The SARS-CoV-2 Process Control (Pellet) is made with RNA transcripts containing diagnostically relevant targets (CDC and WHO consensus sequences) encapsulated in a phage protein.
Nucleotides contained in each pellet (All positions in reference to GenBank Acc. NC_045512.2)

• Orf1ab/RdRP: 12,690 ..12,797 | 13,342 ..13,460 | 14,080 ..14,186 | 15,431 ..15,530

• S (Spike): 18,778 ..18,909 | 24,354 ..24,900

• E (Envelope): 26,245 ..26,427 | 26,269 ..26,381

• N (Nucleocapsid): 28,237 ..29,280

Includes human respiratory epithelial cells

RUO

Catalog number: R9000

Taxonomy: Viruses

Industry Type: Clinical

SARS-CoV-2 Process Control IFU

RUO SARS-CoV-2 Process Control (Swab)
Artikelkod R9001

SARS-CoV-2 Process Control can be used for SARS-CoV-2 assay development, full process control (including extraction), sample adequacy control and spike-in controls. Each kit contains 6 individually packaged lyophilized swabs.

Biosafety Level: 1
Product Format: Helix Elite™ Synthetic Standard
Strain Characteristics: The SARS-CoV-2 Process Control (Swab) is made with RNA transcripts containing diagnostically relevant targets (CDC and WHO consensus sequences) encapsulated in a phage protein.
Nucleotides contained in each swab (All positions in reference to GenBank Acc. NC_045512.2)
• Orf1ab/RdRP: 12,690 ..12,797 | 13,342 ..13,460 | 14,080 ..14,186 | 15,431 ..15,530
• S (Spike): 18,778 ..18,909 | 24,354 ..24,900
• E (Envelope): 26,245 ..26,427 | 26,269 ..26,381
• N (Nucleocapsid): 28,237 ..29,280
Includes human respiratory epithelial cells.
RUO
Catalog number: R9001
Taxonomy: Viruses
Industry Type: Clinical

SARS-CoV-2 Process Control IFU




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