Development of sub-20 minute PCR-based diagnostic assays for a current point of care testing device

Access to a community-based diagnostic infrastructure providing prompt, inexpensive and accurate testing is an unmet patient need highlighted by the COVID-19 pandemic. This must be addressed now, given the significant risk of more variants of SARS-CoV-2 arising [1].

We plan to exploit our paradigm-changing polymerase chain reaction (PCR) chemistry [2] to develop assays that specifically accelerate test times on an existing Point-of-care testing (PoCT) device, the Optigene Genie 3.

PoCT permits earlier diagnosis, results in fewer hospitalisations, lessens risks of infection, and decreases additional costs of referrals and further testing [3].

Its uptake has been hampered by the high cost per test, quality assurance issues and inadequate analytical performance [4].

The Genie 3 has been evaluated for use in the NHS [5] and is used for isothermal PoCT for SARS-CoV-2 detection [6] and more general use [7].

Its use as a real-time PCR cycler is limited by its slow ramp rates and hour-long run times, a universal problem deterring the use of PCR-based PoCT.

Our innovative PCR assay designs and protocols exploit the untapped speed potential of the PCR, thus minimising the Genie 3 s major disadvantage (slow cycling speed) whilst maximising its advantages (size, portability, flexibility, low cost).

Assays will be run on existing devices, resulting in a PCR-based local diagnostic infrastructure capable of delivering eight test results per device in less than 20 minutes.

The combination of a device familiar to NHS staff, novel assays, low reagent usage and speed will address the main concerns hindering clinical PoCT uptake and can be applied to multiple conditions other than infectious diseases.