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Direct-to-PCR COVID-19 Testing - Enhancing sensitivity

C: Further assessment

The Novacyt Group specialises in molecular testing technologies. Primerdesign, a part of the Novacyt Group, has a track record of developing in vitro diagnostics and led the world in the assay development response to COVID-19.

 

Continuing these efforts, our research and development team have screened a variety of extraction-free viral testing protocols and are currently in the process of validating the lead candidate approach.

 

Based on our preliminary analytical data, we are submitting the idea of an extraction-free COVID-19 test, utilising a PCR-enhancing COVID-19 Testing Buffer to counteract reductions in sensitivity typically observed in extraction-free strategies.

 

Background

Principles of Extraction

The isolation of genetic material from patient samples (otherwise known as nucleic acid extraction) is a core part of diagnostic testing and requires the following processing steps:

  1. Lysis – where genetic material is released from cells / viral encapsulation proteins
  2. Binding – where genetic material is selective bound to a matrix which can then be separated from the patient’s other biological material
  3. Washing – where the genetic material is washed whilst bound to the binding matrix
  4. Elution – where the genetic material is released from the matrix

 

 

Challenges Associated with Extraction

  • Extraction processing steps typically confer an additional 30 minutes to the patient testing workflow
  • The demand imposed by the current COVID-19 pandemic has led to a global shortfall in the availability for extraction kit reagents (including both total nucleic acid and RNA-specific extraction, COVID-19 is an RNA virus).

This means that the process of extraction not only reduces testing capacity but also presents a significant supply chain risk during this pandemic.

 

Challenges Associated with Extraction-free Protocols

Several research groups have described COVID-19 testing approaches which obviate the need for extraction. These take advantage of the labile nature of the COVID-19 protein coat which allows for easy access to the viral genetic material.

Despite this, there are significant challenges to applying any extraction-free approach across multiple laboratories:

  • Most patient samples are collected in either Universal Transport Medium (UTM) and Viral Transport Medium (VTM). These media contain chemicals that will interfere with the diagnostic test accuracy and sensitivity.
  • Almost all COVID-19 diagnostic tests utilise the polymerase chain reaction (PCR) technology. The chemical composition of a PCR is dictated by a reagent known as ‘master mix’ and can differ significantly between manufacturers. Some master mixes will be able to withstand the direct addition of transport media, whilst others will not.

Consequently, any extraction-free protocol must include measures to counteract the impact of the PCR inhibitors in a ‘master mix-specific’ fashion.

Concluding Proposal

The Novacyt Group propose an extraction-free protocol which includes a developmental reagent to counteract any losses in sensitivity seen in direct-to-PCR testing. This protocol can be applied upstream of any PCR test but must be used in conjunction with the Primerdesign oasig Master Mix for optimal results.

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

See attached document

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

Upon clinical validation, Primer design can begin manufacturing within 2 weeks via our rapid development authorisation process.

What is the likely production volume?​

960,000 reactions per week

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

None identified

Who are you already partnering with on this?

No partners

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Sonia Gandhi Apr 19, 2020

Status label added: C

Reply 0

Bev Matthews Apr 26, 2020

The idea has been progressed to the next milestone.

Reply 0

Blad3sharp May 11, 2020

Is there any progression with this it seems to of stalled - no updated for over 2 weeks

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