Page banner

#TestingMethods2020

PerkinElmer Influenza A/B, RSV and SARS-CoV-2 Detection Assay

C: Further assessment

The PerkinElmer Influenza A/B, RSV and SARS-CoV-2 assay is a multi-functional panel designed to aid in the detection of various respiratory pathogens.

The assay is based on RT-PCR technology and leverages a similar workflow to the PerkinElmer SARS-CoV-2 real time RT-PCR assay. The kit includes all reagents and control material required to run the assay.

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

The PerkinElmer Influenza A/B, RSV and SARS-CoV-2 panel is currently under development. It is expected that this validation will be completed in the next 4-5 weeks.

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

Whilst the PerkinElmer Influenza A/B, RSV and SARS-CoV-2 panel is currently in development, the existing SARS-CoV-2 detection assay is currently in use at a number of UK hospitals and other clinical settings.

Additionally, other PerkinElmer platforms, such as the Chemagen 360 Viral RNA Extraction platform, are in use at other hospital sites across the UK.

Where is the kit manufactured?

PerkinElmer is a global company with multiple manufacturing sites, our current sites for the manufacturing of RT-PCR based assays are Turku (Finland), Austin (USA) and Taicang (China).

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

The turn around time for this assay, from sample-to-result is approximately 3-4 hours.

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

PerkinElmer’s proposed solution does not include an RT-PCR platform, the kit is compatible with many commercially available RT-PCR which are able to interface directly with a LIMS system.

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

Once validation of the kit has been completed, the kit can be rapidly deployed. The PerkinElmer Influenza A/B, RSV and SARS-CoV-2 panel will use the same workflow as the PerkinElmer SARS-CoV-2 detection assay and is designed to enable quick incorporation into an existing SARS-CoV-2 detection workflow within a laboratory.

The PerkinElmer Influenza A/B, RSV and SARS-CoV-2 detection assay is compatible with a wide range of RT-PCR systems from various suppliers.

What is the likely production volume?

PerkinElmer is anticipating production capacity of 1,000,000 tests per week.

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

PerkinElmer does not anticipate any significant risks or barriers from offering this kit at scale, owing to a robust supply chain and a number of global manufacturing sites.

Through setting up standing orders for kits, we are better able to anticipate and manage demand through planning at a factory level.

Finally, as the kits leverage existing molecular biology infrastructure already in place in labs running an RT-PCR-based assay for the detection of SARS-CoV-2, rapid deployment is possible at scale as there is no reliance on the procurement and installation of additional hardware.

Who are you already partnering with on this?

PerkinElmer has received input on the design of this panel from various clinical laboratories. PerkinElmer will perform all R&D, validation and manufacturing of this kit.  

Steph Wilbraham

Attach files

@

Bev Matthews 7 months ago

Status label added: C: Further assessment

Reply 0

Bev Matthews 7 months ago

Thanks Steph, the champions are interested to hear more when you have information available in the coming weeks. Thanks Bev

Reply 0

Steph Wilbraham 7 months ago

Hi Bev, Thanks for this. I will be in touch when we have further details. Best Wishes, Steph

Reply 1

Bev Matthews 7 months ago

Thank you Steph

Reply 0

Share