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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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Blood Culture Identification Control Panel (43 Targets)
8254

Blood Culture Identification Control Panel (43 Targets) contains six inactivated pre-pooled positive control 1 pellets, six inactivated pre-pooled positive control 2 pellets, and 6 inactivated negative control pellets (18 vials/pellets total). The negative control pellets are blank and do not contain microorganisms.

BCID2 Positive Control 1 (six vials/pellets):

  • Bacteroides fragilis
  • Klebsiella aerogenes
  • Salmonella Typhimurium
  • Stenotrophomonas maltophilia
  • Enterococcus faecium (vanA/B)
  • Staphylococcus lugdunensis
  • Candida auris
  • Cryptococcus neoformans
  • Klebsiella pneumoniae (OXA-48)
  • Escherichia coli (NDM, CTX-M)
  • Klebsiella pneumoniae (VIM-1)
  • Escherichia coli (mcr-1, ESBL)

BCID2 Positive Control 2 (six vials/pellets):

  • Candida albicans
  • Candida krusei
  • Neisseria meningitidis
  • Pseudomonas aeruginosa
  • Staphylococcus aureus (MRSA)
  • Streptococcus agalactiae (Group B)
  • Streptococcus pyogenes
  • Acinetobacter baumannii
  • Candida glabrata
  • Candida tropicalis
  • Enterobacter cloacae (CTX-M)
  • Enterococcus faecalis (vanB)
  • Escherichia coli (IMP)
  • Klebsiella oxytoca
  • Listeria monocytogenes
  • Staphylococcus epidermidis
  • Candida parapsilosis
  • Haemophilus influenzae
  • Klebisella pneumoniae (KPC)
  • Proteus vulgaris
  • Serratia marcescens
  • Streptococcus pneumoniae

BCID2 Negative Control (six vials/pellets): Blank Pellet

 

Norovirus GII.4 Synthetic RNA
HE0012S


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

Biosafety Level 1
Product FormatHelix Elite™ Synthetic Standard
Strain CharacteristicsORF1-ORF2 Junction of Norovirus GII.4

Dried RNA Preserved with Biomatrica RNAstable®

IVD
Test MethodMolecular Testing
Catalog numberHE0012
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Norovirus GI.1 Synthetic RNA
HE0013S


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

Biosafety Level 1
Product FormatHelix Elite™ Synthetic Standard
Strain CharacteristicsORF1-ORF2 Junction of Norovirus GI.1

Dried RNA Preserved with Biomatrica RNAstable®

IVD
Test MethodMolecular Testing
Catalog numberHE0013
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Adenovirus 2 Helix Elite
HE0026N

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
Strain CharacteristicsStrain Adenoid 6

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0026N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Rotavirus Helix Elite
HE0027N


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
Strain CharacteristicsStrain Simian Rotavirus SA11

Medium-high titer

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0027N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Respiratory Syncytial Virus A Helix Elite
HE0028N


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
Strain CharacteristicsStrain Long

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0028N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Influenza A (H1N1) Virus Helix Elite
HE0029N

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
Strain CharacteristicsStrain Subtype H1N1

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0029N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Influenza B Virus Helix Elite
HE0030N


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
Strain CharacteristicsStrain Hong Kong/5/72

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0030N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Parainfluenza Virus 1 Helix Elite
HE0031N


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
Strain CharacteristicsStrain VP1

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0031N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Parainfluenza Virus 2 Helix Elite
HE0032N


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
Strain CharacteristicsStrain Greer

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0032N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Parainfluenza Virus 3 Helix Elite
HE0033N


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
Strain CharacteristicsStrain C243

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0033N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Chlamydia pneumoniae Helix Elite
HE0034N

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
Strain CharacteristicsThis strain of Chlamydia pnuemoniae is sourced from Microbix Biosystems

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0034N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyBacteria
Industry TypeClinical

Inactivated Chlamydia trachomatis Helix Elite
HE0035N

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
Strain CharacteristicsStrain LGV-2-434

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0035N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyBacteria
Industry TypeClinical

Inactivated Herpes Simplex Virus 1 Helix Elite
HE0036N


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
Strain CharacteristicsStrain MacIntyre

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0036N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Herpes Simplex Virus 2 Helix Elite
HE0037N


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
Strain CharacteristicsStrain MS

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0037N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Varicella Zoster Virus Helix Elite
HE0038N


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
Strain CharacteristicsStrain VZ-10

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0038N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Cytomegalovirus Low Control
HE0039N


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
Strain CharacteristicsStrain AD-169

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0039N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Cytomegalovirus High Control
HE0040N


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
Strain CharacteristicsStrain AD-169

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0040N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Neisseria gonorrhoeae Helix Elite
HE0041N


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
Strain CharacteristicsStrain GL0071

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0041N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyBacteria
Industry TypeClinical

Inactivated Trichomonas vaginalis
HE0042N


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
Strain CharacteristicsStrain GL0028

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0042N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyParasites

Inactivated Influenza A (H3N2) Virus Helix Elite
HE0043N


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
Strain CharacteristicsStrain Subtype H3N2

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0043N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Influenza A/B and Respiratory Syncytial Virus
HE0044N


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: Influenza A (H1N1) Virus
Influenza B Virus, Strain Hong Kong/5/72
Respiratory Syncytial Virus (RSV) A, Strain Long

Biosafety Level 1
Product FormatHelix Elite™ Inactivated Standard
Strain CharacteristicsInfluenza A (H1N1) Virus

Influenza B Virus, Strain Hong Kong/5/72

Respiratory Syncytial Virus (RSV) A, Strain Long

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0044N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical

Inactivated Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG)
HE0045N

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
Strain CharacteristicsChlamydia trachomatis Strain LGV-2-434

Neisseria gonorrhoeae Strain GL0071

For in vitro diagnostic use
Test MethodMolecular Testing
Catalog numberHE0045N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyBacteria
Industry TypeClinical

Inactivated Borrelia burgdorferi
HE0052N

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
Test MethodMolecular Testing
Catalog numberHE0052N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyBacteria
Industry TypeClinical

Methicillin-Resistant Staphylococcus aureus (MRSA) Inactivated Swab
HE0053NS


Each kit includes six individually packaged swabs containing Methicillin-Resistant Staphylococcus aureus (MRSA) and a Certificate of Analysis.

Biosafety Level 1
Product FormatHelix Elite™ Inactivated Standard
Catalog numberHE0053NS
Permits and RestrictionsExport Restrictions May Apply
TaxonomyBacteria
Industry TypeClinical

Methicillin-Susceptible Staphylococcus aureus (MSSA) Inactivated Swab
HE0054NS


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

Biosafety Level 1
Product FormatHelix Elite™ Inactivated Standard
Catalog numberHE0054NS
Permits and RestrictionsExport Restrictions May Apply
TaxonomyBacteria
Industry TypeClinical

Methicillin-Susceptible Staphylococcus epidermidis (MSSE) Inactivated
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
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
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)
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

Inactivated Zika Virus
HE0059N

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 Level1
Product FormatHelix Elite™ Inactivated Standard
Test MethodMolecular Testing
Catalog numberHE0059N
Permits and RestrictionsExport Restrictions May Apply
TaxonomyViruses
Industry TypeClinical
SARS-CoV-2 Synthetic RNA (N Gene Targets)
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)
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)
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 Level 1
Product Format Helix Elite™ Inactivated Standard
Strain Characteristics The 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 Method Molecular Testing
Catalog number HE0065N
Permits and Restrictions Export Restrictions May Apply
Taxonomy Viruses
Industry Type Clinical

Inactivated SARS-CoV-2 Whole Virus (Swab)
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 Level 2
Product Format Helix Elite™ Inactivated Standard
Strain Characteristics The 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 Method Molecular Testing
Catalog number HE0066NS
Permits and Restrictions Export Restrictions May Apply
Taxonomy Viruses
Industry Type Clinical

Negative Cellularity Control (Inactivated Swab)
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.

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