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Positive Controls for Molecular Assays

Microbiologics, the leading provider of test ready biological controls, has all the controls your lab needs for validation, verification, proficiency and QC of molecular instruments and assays including:

   • Inactivated, full process controls
   • Synthetic nucleic acids, amplification and detection controls
   • Prepared microorganisms for culture methods
​   • QC Sets and Panels designed specifically for instrumentation and regulatory standards


Safe, Simple, Stable Molecular Controls

Helix Elite™ Molecular Standards, available in synthetic nucleic acid and inactivated formats, are non-hazardous controls designed for use with molecular assays.

   • Compatible with a variety of instruments, kits and applications
   • Convenient test-ready formats save you time and money
   • Easy and economical storage - room temperature storage
​   • FDA listed and CE Marked as an In-Vitro Diagnostic (IVD) Medical Device

​The Products
QC Sets and Panels: Helix Elite™ Catalog No. 8191

Extended Enteric Bacterial Verification Panel (Inactivated Pellet)

Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the 8 organisms listed below:

  S. typhimurium derived from     NCTC 74
  S. sonnei derived from NCTC   12984
  E. coli derived from CDC 2010C-   3114 (STEC) 
  C. jejuni derived from NCTC 11322
  P. shigelloides derived from   NCTC 10363
 Y. enterocolitica derived from   NCTC 11174
  E. coli derived from NCTC 11602     (ETEC)
  V. parahaemolyticus derived   from NCTC 13209
QC Sets and Panels: Helix Elite™ Catalog No. 8184

Enteric Pathogens Control Panel (Inactivated Pellet)
 
Enteric Pathogens Control Panel (Inactivated Pellet) includes two pools: one positive pool and one negative pool. Kits contain five vials of each pool (ten vials total) and feature color coordinated labels for easy pool identification. 

Pool 7
  • C. jejuni 
  • E. coli (STEC)
  • Rotavirus SA11
  • Recombinant Norovirus GII.4
  • S. sonnei 
  • S. Typhimurium
  • V. parahaemolyticus 
  • Y. enterocolitica
Pool 8
  • C. difficile (NAP1/027)
QC Sets and Panels: Helix Elite™ Catalog No. 8211

Enteric Viral Control Panel
 

Enteric Viral Control Panel includes six inactivated microorganism pellets each comprised of the five organisms listed below:

  • Adenovirus 40
  • Recombinant Astrovirus
  • Recombinant Norovirus GII
  • Rotavirus
  • Recombinant Sapovirus

QC Sets and Panels: Helix Elite™ Catalog No. 8210

Enteric Viral Verification Panel
 

Enteric Viral Verification Panel includes 20 inactivated microorganism pellets each comprised of the 5 organisms listed below:

  • Adenovirus 40
  • Recombinant Astrovirus
  • Recombinant Norovirus GII
  • Rotavirus
  • Recombinant Sapovirus
QC Sets and Panels: Helix Elite™ Catalog No. 8205

Norovirus Control Panel (Inactivated Swab) 
Norovirus Control Panel (Inactivated Swab) includes 6 positive control swabs, 6 negative control swabs, and a Certificate of Analysis.

The positive control includes:
Recombinant Norovirus GI.1 (ORF1-ORF2)
Recombinant Norovirus GII.4 (ORF1-ORF2)

The negative control includes Rotavirus



QC Sets and Panels: Helix Elite™ Catalog No. 8230

Enteric Parasite Verification Panel (Inactivated Pellet) 
​

Enteric Parasite Control Panel (Inactivated Pellet) contains six inactivated, pre-pooled pellets comprised of the microorganisms listed below (six vials total):

  • Cryptosporidium parvum 
  • Entamoeba histolytica surrogate
  • Giardia lamblia



QC Sets and Panels: Helix Elite™ Catalog No. 8227

C. difficile Control Panel (Inactivated Swab)
 
C. difficile Control Panel (Inactivated Swab) contains six positive control swabs, six negative control swabs, and a Certificate of Analysis.

  • Positive Control (six swabs): Clostridioides difficile
  • Negative Control (six swabs): Clostridioides sordellii
Download Molecular-CONTROLS Catalogue PDF
Download Culture-BASED CONTROLS catalogue PDF
Helix Elite™ Molecular Standards
Inactivated Controls: 
Kit containing inactivated pellets or swabs that mimic

patient sample processing. Packaged in a plastic container. Also available in QC
Sets and Panels. Room temperature storage. For in vitro diagnostic (IVD) use



​​Genomic Extracts:
 Kit containing one vial of Genomic DNA, one vial of 
molecular standard water for rehydration and Ceritifcate of Analysis. Packagedin a plastic container
​


Synthetic Nucleic Acids: 
Kit containing one vial of dried synthetic DNA or 
RNA (approximately 100 reactions), one vial of molecular standard water for rehydration and Certificate of Analysis. Packaged in a plastic container. Also available in QC Sets and Panels. For in vitro diagnostic (IVD) use. (HE0024) Pan Mycoplasma Synthetic DNA is non-IVD and not intended for clinical use.)



Unassayed





At Least 106
Copies/Pellet







​
Unassayed

 Full Process Control Used for Extraction Through Detection

• Sensitivity • Specificity • Validation & Verification
• Assay Optimization • Training • Proficiency Testing
• Lot-to-Lot Testing • Diagnostic System and Assay QC

• Amplification/Detection Control • Sensitivity • Specificity
• Validation & Verification • Assay Optimization • Training
• Proficiency Testing • Lot-to-Lot Testing
• Molecular Instruments and Assays Q

​• Amplification/Detection Control
• Sensitivity • Specificity
• Validation & Verification
• Assay Optimization
• Training
• Proficiency Testing
• Lot-to-Lot Testing
• Molecular Instruments and Assays QC

    How can we help?

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​Brindley Court, Victoria Business Park
Knypersley ST8 7PP
T: 01782 516 010 
E: [email protected]

  • Home page
  • Contact BioConnections
  • MolecularControls
  • CoVID Controls
  • REFERENCE STRAINS
  • Parasitology
  • Eazyplex® Range
    • eazyplex® AMR
    • eazyplex® C. difficle
    • eazyplex® BloodScreen
    • eazyplex® TyphiTyper
    • eazyplex® VRE
    • eazyplex® EHEC
    • eazyplex® STI
    • eazyplex® CSFdirect
    • eazyplex® MRSA
    • eazyplex® PneumobBug
    • eazyplex Pneumocystis jirovecii
    • eazyplex® hv-K. pneumoniae
  • MBLO blog