Canada COVID-19 Challenge: Magnetic reagents for detection of COVID-19 and other RNA based molecular diagnostic kits

Open DNA Collections Molecular Diagnostics Protocols
1

Hi All

You might be interested in the technology specifications in this Canadian funding call, where they obviously thought quite a lot about characteristics. Is anyone working on local magnetic bead protocols?

Jenny

COVID-19 Challenge: Magnetic reagents for detection of COVID-19 and other RNA based molecular diagnostic kits

Essential (mandatory) outcomes

The solution must:

Phase 1
  1. Demonstrate a method for reagents formulation that is scalable and rapidly adaptable/customizable for different viral threats.
  2. As an immediate test case, demonstrate high specificity for COVID-19 RNA extraction.
  3. Be compatible with most clinical sample types (saliva, sputum, blood, swab, urine, as well as anycell-free media).
  4. Possess the ability to isolate and purify 1 copy/µL or less of viral RNA.
  5. Be rapid, within 15 minutes or less, and require a minimum number of manipulation steps to arrive at final solution.
  6. Introduce a complete solution, including lysis, extraction, washing, and elution into appropriate buffer.
  7. Integrate with downstream molecular diagnostics including RT-qPCR.
  8. Be compatible with most RT-qPCR reagents and buffers.
  9. Provide high extraction efficiencies without leading to false negatives, and be superior to gold standard spin-column methods.
  10. Provide high quality SARS-CoV-2 RNA preps for diagnostic use – devoid of any protein, lipid or other contaminants.
  11. Be customizable to microfluidic platforms for medical device sample-to-answer and sample preparation systems – in particular formulation that can be stored in dry and/or liquid formats in microfluidic polymer cartridges without losing efficacy.
  12. Be compatible with magnetic bead-based automated and high throughput applications.
  13. Integrate seamlessly with most robotic automated systems such as Thermo KingFisher, PerkinElmer Chemagic, and Roche MagNA Pure.
Phase 2
  1. Provide enough fabrication capacity of reagents that can feed fabrication of up to 100 000 tests /month. The reagents formulation must be compatible with room temperature storage for up to 6 months allowing for clinical deployment in distributed testing sites.
  2. Demonstrate, at the end of Phase 2, clinical efficacy data derived from a clinical trial comparing the buffer/reagents to the performance of the current gold standard for COVID-19 viral RNA extraction for downstream RT-qPCR. The gold standard is spin-column based kits, as well as other magnetic-based kits from well-known suppliers such as Qiagen, ThermoFisher, and Roche. Gold standard testing can be performed by the NRC or an accredited lab provided the samples are submitted in a blinded and anonimised fashion.
  3. Trial design should follow a non-inferiority trial design.
  4. Be amenable to scale-up manufacturing and not be hindered by foreign supply chain issues.