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
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
| Cell Bio Catalogue No. | Details |
|---|---|
| MBHE0065N | Inactivated SARS-CoV-2 Whole Virus (Pellet) |
| MBHE0066NS | Inactivated SARS-CoV-2 Whole Virus (Swab) |
| Cell Bio Catalogue No. | Details |
|---|---|
| MBHE0062S | SARS-CoV-2 Process Control (Pellet) |
| MBHE0063S | SARS-CoV-2 Process Control (Swab) |
| MBHE0058N | Negative Cellularity Control (Inactivated Pellet) |
| MBHE0059N | Inactivated Zika Virus Control |
| 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) |
| Cell Bio Catalogue No. | Details |
|---|---|
| MB8234 | Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet) |
| MB8235 | Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet) |
| Cell Bio Catalogue No. | Details |
|---|---|
| MB8234 | Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet) |
| MB8235 | Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet) |
| Cell Bio Catalogue No. | Details |
|---|---|
| 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.
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
1. Sensitivity/Specificity
2. Extraction/Amplification
3. Presence/Absence
4. Validation/Verification
5. Proficiency/Training
6. Assay Optimization
7. Lot-to-Lot Testing
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
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
1. Sensitivity/Specificity
2. Extraction/Amplification
3. Presence/Absence
4. Validation/Verification
5. Proficiency/Training
6. Assay Optimization
7. Lot-to-Lot Testing
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
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
1. Sensitivity/Specificity
2. Extraction/Amplification
3. Presence/Absence
4. Validation/Verification
5. Proficiency/Training
6. Assay Optimization
7. Lot-to-Lot Testing
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