May 2020 Press Release
Rapid Labs Ltd (Essex, UK), RNAssist (Cambridge, UK) and Qnostics (Glasgow, UK) are currently developing and seeking trial sites to validate the virusPHIX™ RNA stabilisation, cell fixative and virus inactivation reagent for SARS-CoV-2 testing on nasopharangeal swab samples and saliva/sputum samples.
Offer; A universal sample collection tube for liquid samples including; blood, plasma, serum, saliva, sputum, nasal mucus, tears, faeces, cells and urine containing virusPHIX™ virus inactivation and viral RNA stabilisation reagent. Succesful validation could enable virusPHIX™ to be used as an effective virus transport medium for COVID-19 testing, allowing safer handling and transport whilst simultaneously preserving the RNA integrity for molecular testing..
Existing validation performed:
(1) Virus Inactivation:
The virusPHIX™ reagent inactivates all tested viruses including Vaccinia, BVDV, FIV, Duck HepB, Dengue and Influenza A (CDC, Pasteur Institute, and BluTest Ltd) and on this basis it should equally inactivate SARS-CoV-2. In addition, virusPHIX™ has been shown to inactivate Staphylococcus aureus, Pseudomonas aeruginosa and Listeria, and knocks-down Candida albicans by 3-logs. virusPHIX™ has also been used to inactivate a Cat. 3 virus (Dengue) allowing handling in a Cat. 2 lab, as well as a Cat. 2 virus (Influenza A H1N1) for shipping (Pasteur Institute). The reagent has been evaluated by over 240 researchers including the Universities of Oxford and Cambridge, NIBSC, Pasteur, Sanger, CDC and MIT.
(2) Stabilisation of SARS-CoV-2:
Preliminary data demonstrates that virusPHIX™ completely stabilises SARS-CoV-2 RNA in virus spiked sputum for 33-days at room-temperature and is directly compatible with QIAamp Virus RNA purification and CV E-Gene RT-qPCR. Additionally virusPHIX™ stabilises RNA, DNA and proteins, as one example; 12 month room-temperature liquid stabilisation of 2 strains of HCV in plasma has been achieved with virusPHIX™ as determined by RT-qPCR and shown to be generally equivalent to -80°C storage.
(3) Compatibility with Commercial Purification Kits:
virusPHIX™ is directly compatible with front-end nucleic acid purification platforms including RNeasy™, QIAamp™, QIAsymphony™, QIAcube™, Nuclisens™, GeneXpert™and Filmarray™.
How quickly could this be deployed and what are the dependencies?
A one day batch production process of the reagent has been validated. As an initial proof-of-principle example, 120 virusPHIX™ sample collection tubes have been manufactured, labeled, filled and shipped this week by Rapid Labs Ltd., UK. Raw materials, manufacturing and tube filling facilities are all based in the UK.
What is the likely production volume?
Full production run up to ≥100 Litres which is equivalent to 100,000 sample collection tubes per day. Rapid Labs Ltd., UK can start manufacturing within 1 week; bulk chemicals, filters and vials are all in stock, dispensing equipment installed and a new manufacturing clean room fitted last month. Rapid Labs can initially manufacture 15,000 vials a day and this could be scaled up to 100,000 vials a day within 2 weeks.
What are the risks and barriers to using this at scale?
virusPHIX™ is non-toxic and non-volatile, it is a novel composition and does not contain any reagent (such as guanidine) that is currently used for SARS-CoV-2 RNA purification, therefore there is no direct competition for scarce materials and no known shortages of the raw materials. No known batch effects to volume scale up. Chemicals sourced from a UK supplier.
For further information or to discuss working with us to validate virusPHIX™ for COVID-19 testing please contact us at firstname.lastname@example.org