Helix Elite™ Synthetic DNA/RNA

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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

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

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.

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.

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

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.

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.

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.

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.

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.

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

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