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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
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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
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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:
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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:
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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):
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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.
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
Helix Elite™ Molecular Standards
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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 |
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