HELIX ELITE™ MOLECULAR STANDARDS

For COVID-19 testing quality control and assay development, the SARS-CoV-2 Synthetic RNA (N Gene Targets) provides the complete N gene sequence for the SARS-CoV-2 virus in an easy-to-use format. Microbiologics also offers RUO synthetic RNA with all three markers (N1, N2 and N3) detected by the CDC Real-Time RT PCR Panel for Detection of 2019 Novel Coronavirus.

Helix Elite Molecular Standards are used as controls for developing, validating, and monitoring molecular instruments and assays. These specialized biological controls support molecular technology developers and users in meeting regulatory requirements and providing confidence in their test. We offer three distinct formats for Helix Elite Molecular Standards – Inactivated, Synthetic Nucleic Acids and Genomic Extracts. Each format has been designed for efficiency and usability.

Here's a list of the top benefits Helix Elite products provide:
1. Non-hazardous materials for safe handling
2. Ideal for pathogens which are difficult to grow
3. Optimized for time and labor savings
4. Independent external controls provide accurate, reliable results
5. Convenient room temperature storage

Available Products

Diagnostic System and Syndrome-Specific Non-Assay Specific QC Sets and Panels contain quality control strains suitable to test a variety of instruments or assays in an easy-to-use forma

SARS COVID-19

  Cell Bio Catalog No.   Details
 MBR9001  SARS-CoV-2 Process Control (Swab)
 MBR9000  SARS-CoV-2 Process Control (Pellet)
 MBHE0058N  Negative Cellularity Control (Inactivated Pellet)
 MBHE0060S  SARS-CoV-2 Synthetic RNA (N Gene Targets)
 MBHE0061S  SARS-CoV-2 Synthetic RNA Pool (N/E/RdRp/S Gene Targets)
 MB9009  SARS-CoV-2 Synthetic RNA (N Gene Targets, 1 x 109genome copies per tube)
 MB9019VP  SARS-CoV-2 Synthetic RNA (E/RdRp Gene Targets, 1 x 109 genome copies per tube)
 MB9029VP   SARS-CoV-2 Synthetic RNA (S Gene Targets, 1 x 109 genome copies per tube)

BD MAX™

  Cell Bio Catalog No.   Details
 MB8227  C. difficile Control Panel (Inactivated Swab)
 MB8231  Comprehensive Enteric Bacterial Control Panel
 MB8182  Enteric Parasite Verification Panel (Synthetic)
 MB8179  Enteric Bacterial Organism Set (Live Culture)
 MB8230  Enteric Parasite Control Panel
 MB8191  Extended Enteric Bacterial Verification Panel(Inactivated Pallet)
 MB8211  Enteric Viral Control Panel
 MB8210  Enteric Viral Verification Panel
 MB8232  Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
 MBHE0053NS  Methicillin-Resistant Staphylococcus aureus (MRSA) (Inactivated Swab)
 MBHE0054NS  Methicillin-Susceptible Staphylococcus aureus (MSSA) (Inactivated Swab)
 MBHE0055NS  Methicillin-Susceptible Staphylococcus epidermidis (MSSE) (Inactivated Swab)
 MB8174  MRSA Organism Set (Live Culture)
 MB8178  SA Organism Set (Live Culture)
 MB8173  Strep B Organism Set
 MB8209  Vaginal Control Panel
 MB8208  Vaginal Verification Panel
 MB8228  CT/GC/TV Control Panel (Inactivated Pellet)
 MB8229  Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG)Control Panel (Inactivated Swab)

CEPHEID GENEXPERT®

  Cell Bio Catalog No.   Details
 MB8187  Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel(Inactivated Swab)
 MB8227  C. difficile Control Panel (Inactivated Swab)
 MB8171  C. difficile QC Set (Live Culture)
 MB8190  Enterovirus (EV) Control Panel (Inactivated Swab)
 MB8164  GBS QC Set (Live Culture)
 MB8219  Group A Streptococcus (GAS) Control Panel
 MB8232  Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
 MBHE0053NS  Methicillin-Resistant Staphylococcus aureus (MRSA) (Inactivated Swab)
 MBHE0054NS  Methicillin-Susceptible Staphylococcus aureus (MSSA) (Inactivated Swab)
 MBHE0055NS  Methicillin-Susceptible Staphylococcus epidermidis (MSSE) (Inactivated Swab)
 MB8205  Norovirus Control Panel (Inactivated Swab)
 MB8233  Respiratory (4 Targets) Control Panel (Inactivated Swab)
 MB0360MSSA  Staphylococcus aureus subsp. aureus derived from ATCC® 25923™*(MSSA Live Culture Positive Control)
 MB0158MRSA  Staphylococcus aureus subsp. aureus derived from ATCC® 700699™*(MRSA Live Culture Positive Control)
 MB0371MSSE  Staphylococcus epidermidis derived from ATCC® 12228™* (MSSE Live Culture Negative Control)
 MB8189  Trichomonas vaginalis (TV) Control Panel (Inactivated Swab)
 MB8203  Vancomycin Resistant Enterococcus (VRE) Control Panel(Inactivated Swab)

BD VIPER™

  Cell Bio Catalog No.   Details
 MB8214  Human papillomavirus (HPV) Control Panel (Inactivated Pellet)
 MB8216  Human papillomavirus (HPV) Verification Panel (Inactivated Pellet)
 MB8234 Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
 MB8235 Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)

BIOFIRE® FILMARRAY®

  Cell Bio Catalog No.   Details
 MB8215  Blood Culture Identification (BCID) Control Panel
 MB8201  Blood Culture Identification (BCID) Verification Panel
 MB5229P  Blood Culture Identification (BCID) Verification Panel (Live Culture)
 MB8217  Respiratory Control Panel (21 Targets)

LUMINEX VERIGENE®

  Cell Bio Catalog No.   Details
 MB8184  Enteric Pathogens Control Panel (Inactivated Pellet)
 MB5226P  Gram-Negative Blood Culture Control Panel (Live Culture)
 MB8181  Gram-Negative Blood Culture Control Panel (Inactivated Pellet)
 MB5225P  Gram-Positive Blood Culture Control Panel (Live Culture)
 MB8180  Gram-Positive Blood Culture Control Panel (Inactivated Pellet)
 MB8234 Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
 MB8235 Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)

Hologic Panther

 MB8234 Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
 MB8235 Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)
 MB8240 Mycoplasma genitalium Control Panel (Inactivated Pellet)


Seegene

 MB8234 Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
 MB8235 Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)


Abbott

 MB8234 Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
 MB8235 Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)


Roche

 MB8234 Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
 MB8235 Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)

Note: The above QC material are Medical Device Class 2 with an intended purpose of "Non Assay Specific Bacterial or Viral or Parasitic QC Material not intended for monitoring Class 4 Devices". The end-user should develop their own assay ranges in line with good laboratory practices. QC material is not assay specific to the instrument listed. Cell Biosciences is the Australian sponsor of these Devices.

Inactivated Helix Elite Molecular Standards

Highlights 

1. Fully intact, non-viable process control
2. FDA listed and CE Marked as an In-Vitro Diagnostic (IVD) Medical Device
3. Used for every step of the molecular testing process, from extraction, to amplification and detection
4. Quick dissolving lyophilized pellets may be reconstituted in buffer or transport medium
5. Processed using the same protocols as the patient sample

Applications and test methods

1. Sensitivity/Specificity
2. Extraction/Amplification
3. Presence/Absence
4. Validation/Verification
5. Proficiency/Training
6. Assay Optimization
7. Lot-to-Lot Testing

Package Details

1. Pellet format: 5 unassayed lyophilized microorganism pellets packaged in individual vials
2. Swab format: 6 unassayed swabs containing an intact inactivated microorganism packaged in individual foil pouches
3. Instructions for use
4. Certificate of Analysis

Download Instructions for use


Available Products
 Cell Bio Catalog No.  Details
 MBHE0056N   Human Papillomavirus 16 (HPV 16) Cellularity Control (Inactivated Pellet) 
 MBHE0057N  Human Papillomavirus 18 (HPV 18) Cellularity Control (Inactivated Pellet)
 MBHE0026N  Inactivated Adenovirus 2 
 MBHE0052N  Inactivated Borrelia burgdorferi 
 MBHE0034N  Inactivated Chlamydia pneumoniae
 MBHE0035N  Inactivated Chlamydia trachomatis
 MBHE0045N  Inactivated Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG)
 MBHE0049N  Inactivated Cryptosporidium and Giardia 
 MBHE0040N  Inactivated Cytomegalovirus High Control
  MBHE0039N  Inactivated Cytomegalovirus Low Control
 MBHE0050N  Inactivated Enterovirus D68 
 MBHE0036N  Inactivated Herpes Simplex Virus 1 
 MBHE0037N  Inactivated Herpes Simplex Virus 2
 MBHE0044N  Inactivated Influenza A/B and Respiratory Syncytial Virus
 MBHE0029N  Inactivated Influenza A (H1N1) Virus
 MBHE0043N  Inactivated Influenza A (H3N2) Virus 
 MBHE0030N  Inactivated Influenza B Virus 
 MBHE0041N  Inactivated Neisseria gonorrhoeae 
 MBHE0031N  Inactivated Parainfluenza Virus 1
 MBHE0032N  Inactivated Parainfluenza Virus 2 
 MBHE0033N   Inactivated Parainfluenza Virus 3 
 MBHE0028N   Inactivated Respiratory Syncytial Virus A 
 MBHE0027N  Inactivated Rotavirus 
 MBHE0042N  Inactivated Trichomonas vaginalis
 MBHE0038N   Inactivated Varicella Zoster Virus 
 MBHE0053NS   Methicillin-Resistant Staphylococcus aureus (MRSA) Inactivated Swab 
 MBHE0054NS   Methicillin-Susceptible Staphylococcus aureus (MSSA) Inactivated Swab 
 MBHE0055NS  Methicillin-Susceptible Staphylococcus epidermidis (MSSE) Inactivated Swab 
 MBHE0058N   Negative Cellularity Control (Inactivated Pellet) 


Synthetic Helix Elite Molecular Standards

Highlights 

1. Synthetic nucleic acid RNA and DNA sequences for use as amplification and detection controls in clinical assays
2. Each standard contains consensus sequences of diagnostic regions from the target’s genome, representing the known genetic diversity of the microorganism; ready-to-use with no extraction required
3. Compatible with a variety of instruments, kits and applications

Applications and test methods

1. Sensitivity/Specificity
2. Extraction/Amplification
3. Presence/Absence
4. Validation/Verification
5. Proficiency/Training
6. Assay Optimization
7. Lot-to-Lot Testing

Package Details

1. 1 vial of dried, stabilized RNA or DNA (approximately 100 reactions) 
2. 1 vial of molecular standard water for rehydration
3. Instructions for use
4. Certificate of Analysis

Download Instructions for use


Available  Products
  Cell Bio Catalog No.  Details
 MBHE0001S  Cryptosporidium hominis Synthetic DNA
 MBHE0002S  Cryptosporidium parvum Synthetic DNA
 MBHE0025S  Cyclospora cayetanensis Synthetic DNA
 MBHE0015S  Dientamoeba fragilis Synthetic DNA
 MBHE0016S  Eastern Equine Encephalitis Virus Synthetic RNA
 MBHE0004S  Encephalitozoon intestinalis Synthetic DNA
 MBHE0007S  Entamoeba dispar Synthetic DNA
 MBHE0006S  Entamoeba histolytica Synthetic DNA
 MBHE0003S  Enterocytozoon bieneusi Synthetic DNA
 MBHE0005S  Giardia lamblia Synthetic DNA
 MBHE0046S  MBHuman papillomavirus 16 Synthetic DNA
 MBHE0048S  Human papillomavirus 18 Synthetic DNA
 MBHE0013S  Norovirus GI.1 Synthetic RNA
 MBHE0012S  Norovirus GII.4 Synthetic RNA
 MBHE0024S  Pan Mycoplasma Synthetic DNA
 MBHE0008S  Plasmodium falciparum Synthetic DNA
 MBHE0011S  Plasmodium malariae Synthetic DNA
 MBHE0010S  Plasmodium ovale Synthetic DNA
 MBHE0009S  Plasmodium vivax Synthetic DNA
MBHE0060S SARS-CoV-2 Synthetic RNA (N Gene Targets)
 MBHE0047S  Treponema pallidum synthetic DNA
 MBHE0014S  West Nile Virus Synthetic RNA

Genomic Extract Helix Elite Molecular Standards

Highlights 

1. Used as a positive control for the amplification and detection steps in molecular assays
2. Dried, stabilized and quantitated nucleic acid extracted from target pathogens
3. Each preparation is assessed for purity, integrity and provided with a gene copy number for quantitation
4. Cost effective, reliable results; no extraction required

Applications and test methods

1. Sensitivity/Specificity
2. Extraction/Amplification
3. Presence/Absence
4. Validation/Verification
5. Proficiency/Training
6. Assay Optimization
7. Lot-to-Lot Testing

Package Details

1. 1 vial with at least 106 copies of Genomic DNA
2. Helix Elite™ Molecular Standard Water for rehydration
3. Instructions for use
4. Certificate of Analysis

Download Instructions for use


Available  Products
  Cell Bio Catalog No.   Details
 MBHE1156E  Acholeplasma laidlawii derived from NCTC 10116
 MBHE1180E  Mycoplasma arginini derived from NCTC 10129
 MBHE1176E  Mycoplasma fermentans derived from NCTC 10117
 MBHE1155E  Mycoplasma gallisepticum derived from NCTC 10115
 MBHE1157E  Mycoplasma hominis derived from NCTC 10111
 MBHE1178E  Mycoplasma hyorhinis derived from NCTC 10130
 MBHE1158E  Mycoplasma orale derived from NCTC 10112
 MBHE1177E  Mycoplasma pneumoniae derived from NCTC 10119