HYGIEIAtech.

Setup and Scale-Up of a Commercial Molecular Laboratory

Background:

At the outset of the Covid-19 pandemic it was quickly apparent that local NHS services could not support the amount of personal testing that was mandated upon the UK population and that dedicated mass-scale testing facilities were required for the timely processing of large volumes of nasopharyngeal samples.

Process:

James established a new molecular testing facility in a company with no previous large-scale molecular testing capabilities or experience of clinical testing processes. In what was initially a solo project as Head of Science and Innovation within the R&D department, he procured equipment and materials for personal SARS-CoV-2 testing and rapidly developed and validated an accurate and robust testing method for the detection of viral RNA in nasopharyngeal swabs. Within 3 months, laboratory operations were upscaled from a few dozen tests to more than 5000 tests per day through the implementation of automation, process optimisation and the training of additional laboratory analysts, and the facility became one of the first UK laboratories to attain Department of Health & Social Care (DHSC) approval for private SARS-CoV-2 testing.

The molecular laboratory also undertook clinical validations of commercial SARS-CoV-2 qPCR assays on behalf of industry manufacturers so that their proprietary reagents and protocols could be deployed for testing with DHSC approval, and collaborated with the Covid-19 Genomics (COG) consortium and Sheffield University to implement the ARTIC next-generation sequencing protocol on Oxford Nanopore platforms for whole genome sequencing and variant calling of SARS-CoV-2 positive samples.

Outcomes:

  1. One of the first UK laboratories to be approved by the DHSC for Covid-19 testing, including pre-departure travel testing.

  2. The provision of next-generation sequencing approaches for strain-specific detection of SARS-CoV-2, allowing UK public health services to track the spread and evolution of the virus.

  3. In-house development and UKAS-accreditation of nucleic acid extraction and qPCR assay reagents, resulting in a materials cost saving of up to 90% when compared to commercially available equivalents.