St Cloud, MN – Expanding upon its line of SARS-CoV-2 products, Microbiologics is launching two new products for COVID-19 quality control and research: an RUO protein-coated RNA process control and an IVD control with pooled gene targets.
SARS-CoV-2 RNA Process Control (RUO)
The new SARS-CoV-2 control features diagnostically relevant RNA sequences protected by phage protein, providing nuclease resistance even in nuclease-rich environments such as nasal secretions or plasma. This coating protects the RNA during the extraction process, preventing the false negatives that can occur with the use of naked RNA. The protein coating functions like the virus’s protective envelope that sequesters and protects its RNA genome.
“The accuracy of diagnostic data continues to hamper the global response to COVID-19,” said Cynthia Forsman, Ph.D., molecular research and development scientist who led the project. “The availability of a full SARS-CoV-2 process control which closely mimics a true patient sample, while remaining noninfectious itself, is a critical step forward in the development and validation of COVID-19 assays.”
Featuring genomic targets for all seven WHO COVID-19 testing protocols, this RNA process control can be used for SARS-CoV-2 assay development, positive extraction, and spike-in controls.
| Genomic Region | Included Nucleotides |
| RdRP | 12,690…12,79713,342…13,46014,080…14,18615,431…15,530 |
| S (Spike) | 18,778…18,90924,354…24,900 |
| E (Envelope) | 26,245…26,42726,269…26,381 |
| N (Nucleocapsid | 29,237…29,280 |
This RNA process control also contains human respiratory epithelial cells to verify the complete testing process. The protective protein envelope and the complex matrix of human respiratory epithelial cells allow the process control to mimic a true patient sample. “The design and robustness of this control makes it amenable to a wide range of extraction, capture and molecular biology amplification technologies being used in the global response to COVID19,” stated Forsman.
IVD Control with the RdRp, S, E, and N Gene Targets
In addition to the RUO Process Control, Microbiologics is adding a new SARS-CoV-2 IVD control to the popular Helix Elite™ line of molecular standards. The new SARS-CoV-2 Helix Elite™ control features a pool of large RNA molecules that match the viral sequences for the following genes:
- RdRp gene, which codes for the enzyme RNA-dependent RNA polymerase
- S gene, which codes for the spike glycoproteins found in the viral envelope
- E gene, which codes for the envelope that surrounds the viral shell
- N gene, which codes for the nucleocapsid phosphoprotein found in the shell of the virus
These pooled genetic targets offer broad compatibility with CDC- and WHO-specified test components to generate positive PCR signals. This new IVD control comes with the proven simplicity and convenience of the Helix Elite™ line.
Convenient Formats
The RUO process control is available as a pellet (catalogue # R9000) and a swab (catalogue # R9001). The pooled IVD control is available as a pellet (catalogue # HE0061S).
Shipped and stored at ambient temperature, these synthetic RNA controls are non-infectious and classified as BSL-1.
Partnering with Researchers & Manufacturers to Develop Resources for SARS-CoV-2
If you are an assay developer and don’t see the necessary gene targets for your assay listed above, contact us to request additional gene sequences.
Additional SARS-CoV-2 Quality Control & Research Resources
To view all Microbiologics SARS-CoV-2 IVD and RUO products that are available now and coming soon, visit https://www.microbiologics.com/sars-cov-2-quality-control.
