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COVID-19 Detection Plus Kit (SARS-SoV-2, Flu A/B & RSV)

Following PHE guidelines from previous flu seasons regarding the front line screening protocol of patients presenting with symptoms for Influenza A, Influenza B and Respiratory syncytial virus, GeneFirst have taken the action to develop a RT-PCR multiplex assay for these commonly screened flu pathogens with the addition of SARS-CoV-2. This economic syndromic testing approach will aid in the detection of other common flu pathogens and in turn aid in the management of patients this flu season, especially those deemed at greater risk.

Have you validated this method, if so, how and what were the results of the validation?

Validation is currently being undertaken with a view for CE marking to be finalised by the end of October or beginning of November. Validation data will be available to be shared upon CE marking. 

Is the method already deployed in a UK hospital or clinical setting?

Not currently as the assay is being validated with clinical samples. Clinical partners within the UK and across Europe have agreed to trial the assay once CE marking has been achieved.

Where is the kit manufactured?

At our headquarters within the Culham Science Park, Abingdon, Oxfordshire.

What is the turn around time (sample-to-result) for this method?

Sample to result turnaround time would equate to 90 minutes for 96 reactions. This methodology is easily expedited by overlapping reactions and by the number of plates ran consecutively.

How will your solution communicate directly with the Laboratory Information Management System (LIMS)?

As we are developing the reagents for the RT-PCR reaction (RT Mix, Enzyme Mix, Working Mix and Positive Control). These materials are agnostic and can be used in line with multiple PCR systems already prevalent within clinical sites across the UK. Due to this flexibility, LIMS compatibility is dependant on the systems/equipment used internally at each of the clinical sites.

How quickly could this be deployed and what are the dependencies?

As soon as the assay is CE marked, we will have capacity to deploy the assay across the UK immediately.

What is the likely production volume?

Current capacity will allow us to manufacture 24,000 - 48,000 tests per week. Plans are in place to increase the production volume before the end of the year.

What are the risks and barriers to using this at scale?

No potential risks or barriers have been identified internally. Actions have already been taken to increase resources to ensure our manufacturing and supply chain are as robust as possible.

Who are you already partnering with on this?

We have partnered with a clinical site within the UK to gain access to clinical samples for the validation and CE marking process.

edited on Sep 21, 2020 by Ashay Patel
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