Microbiologics launched the first IVD molecular control for
SARS-CoV-2. in March 2020.
IVD Control
HE0061S
The 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®
HE0062 (pellet) H0063 (swab)
The SARS-CoV-2 Process Control 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
R9000 (pellet) R9001 (swab)
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
The 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.
The first IVD control provides the N1, N2, & N3 gene targets in an easy-to-use format.
Identified by product number HE0060S
NEW 28 April 2020
The new Microbiologics SARS-CoV- 2 molecular control covering more targets, so applicable to more systems. Identified by product number HE0061S
HE0061S SARS-CoV-2 control is a synthetic RNA material 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)
SARS-CoV-2. in March 2020.
IVD Control
HE0061S
The 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®
HE0062 (pellet) H0063 (swab)
The SARS-CoV-2 Process Control 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
R9000 (pellet) R9001 (swab)
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
The 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.
The first IVD control provides the N1, N2, & N3 gene targets in an easy-to-use format.
Identified by product number HE0060S
NEW 28 April 2020
The new Microbiologics SARS-CoV- 2 molecular control covering more targets, so applicable to more systems. Identified by product number HE0061S
HE0061S SARS-CoV-2 control is a synthetic RNA material 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)
More Targets Covered Means more Systems Covered
HE0061S Compatability Chart
Format
Dried RNA Preserved with Biomatrica RNAstable®
IVD Helix Elite™
Synthetic Standard Format. Biosafety level 1
No health and safety risk from exposure
Catalog Number HE0060S
CE marked IVD registered
About Helix Elite™
Molecular diagnostic tests offer rapid and specific information regarding the presence and quantity of a microorganism (e.g., bacterium, parasite, virus, etc).
Development and proper interpretation of a molecular diagnostic test requires the use of a positive control. A positive control confirms the proper performance of a molecular assay and operator.
Synthetic Helix Elite™ Molecular Standards are nucleic acids created for use as positive control surrogates for various microorganisms and viruses where target genomic material may be difficult or unsafe to obtain.
Molecular diagnostic tests offer rapid and specific information regarding the presence and quantity of a microorganism (e.g., bacterium, parasite, virus, etc).
Development and proper interpretation of a molecular diagnostic test requires the use of a positive control. A positive control confirms the proper performance of a molecular assay and operator.
Synthetic Helix Elite™ Molecular Standards are nucleic acids created for use as positive control surrogates for various microorganisms and viruses where target genomic material may be difficult or unsafe to obtain.
