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Bosphore SARS-CoV-2/Respiratory Pathogens Panel kit v1 (Anatolia Geneworks) from Launch Diagnostics

Three tubes multiplex real-time PCR for the detection of:

  • N-gene and the orf1ab gene (including the RdRp region) for SARS-CoV-2
  • Flu A & B (no differentiation)
  • RSV A & B (no differentiation)
  • Adenovirus
  • Enterovirus
  • Metapneumovirus
  • Rhinovirus
  • Legionella pneumophila
  • Mycoplasma pneumoniae
  • Parainfluenza 1 - 4 (no differentiation)
  • Human cellularity control RNase P

 The targets detected in the kit covers all of the ones listed in Group 4 of the PHE winter strategy testing document.

The kit is compatible with many extraction and real-time PCR systems already found in UK laboratories.

Launch Diagnostics and its partners Anatolia Geneworks and Alpha IVD (Anatolia’s Italian subsidiary) have been at the forefront of the SARS-CoV-2 testing since the beginning of the pandemic. Two new kits have now been developed and will be available soon to answer to the customer’s needs of having SARS-CoV-2 included in Respiratory panels: SARS-CoV-2/Flu/RSV panel and SARS-CoV-2/Respiratory Pathogens Panel kit v1.

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

The new SARS-CoV-2/Respiratory Pathogens Panel kit v1 is a mix of 2 CE marked kits already in use in many labs in the UK: the Bosphore Respiratory Pathogens panel kit v6 and the Bosphore 2019-nCoV detection kit v2.

This new combined kit is currently undergoing validation and is expected to be available and CE marked by Fall 2020.

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

Not yet as it is still been validated.

Where is the kit manufactured?

The kit is manufactured in Istanbul (Turkey) and Milan (Italy).

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

It depends on the extraction method used, but approximately 2 hours 30 minutes.

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

Real-time PCR instruments such as the Thermofisher ABI 7500, Thermofisher QuantStudio 5 and Roche LightCycler 480 II can be used with this kit. Such instruments can be interfaced to the LIMS

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

As the distributor of these kits in the UK, we at Launch Diagnostics will be holding stock, with deliveries arriving weekly.

The dependencies could be the shipping from Europe, and the continual supplies of plastics & packaging for the kits.

What is the likely production volume?

Up to 500,000 tests per week.

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

The limiting factor will be the availability of the extraction reagents (as a distributor of these reagents we have been increasing our stocks) and the PCR consumables, for example PCR plates/tubes, etc.

Who are you already partnering with on this?

Launch Diagnostics are partnered with Anatolia Geneworks through their Italian sister company Alpha IVD based in Italy.

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