1887

Journal of Medical Microbiology logo

Volume 70, Issue 4

Development, deployment and in-field demonstration of mobile coronavirus SARS-CoV-2 Nucleic acid amplification test Open Access

Abstract

The evolving SARS-CoV-2 coronavirus pandemic presents a series of challenges to clinical diagnostic services. Many proprietary PCR platforms deployed outside centralised laboratories have limited capacity to upscale when public health demands increase. We set out to develop and validate an open-platform mobile laboratory for remote area COVID-19 diagnosis, with a subsequent field trial.

In regional Western Australia, molecular diagnostic support is limited to near point-of-care devices. We therefore aimed to demonstrate open-platform capability in a rapidly deployable format within the context of the COVID-19 pandemic.

We compared, selected and validated components of a SARS-CoV-2 RT-PCR assay in order to establish a portable molecular diagnostics laboratory. The optimal combination of PCR assay equipment, reagents and consumables required for operation to national standards in regional laboratories was identified. This comprised RNA extraction and purification (QuickGene-480, Kurabo, Japan), a duplex RT-PCR assay (Logix Smart COVID-19, Co-Diagnostics, USA), a Myra liquid handling robot (Biomolecular Systems, Australia) and a magnetic induction thermal cycler (MIC, Biomolecular Systems).

The 95 and 99% limits of detection were 1.01 copies μl (5.05 copies per reaction) and 2.80 copies μl (14.00 copies per reaction) respectively. The Co-Diagnostics assay amplified both SARS-CoV-1 and −2 RNA but showed no other cross reactivity. Qualitative results aligned with the reference laboratory SARS-CoV-2 assay (sensitivity 100% [95 % CI 96.48–100%], specificity 100% [95% CI 96.52–100%]). In field trials, the laboratory was operational within an hour of arrival on-site, can process up to 36 samples simultaneously, produces results in two and a half hours from specimen reception, and performed well during six consecutive runs during a 1 week deployment.

Our mobile laboratory enables an adaptive response to increased test demand, and unlike many proprietary point-of-care PCR systems, rapid substitution with an alternative assay if gene targets change or reagent supply chains fail. We envisage operation of this RT-PCR assay as a standby capability to meet varying regional test demands under public health emergency operations guidance.

  • Received:
  • Accepted:
  • Published Online:
Keyword(s): coronavirus , COVID-19 , diagnostic test performance , mobile laboratory , molecular diagnostics , nucleic acid test , RT-PCR and SARS-CoV-2
Funding
This study was supported by the:
  • Lab Without Walls
    • Principle Award Recipient: TimothyJ. J. Inglis
  • Northern Star Resources
    • Principle Award Recipient: TimothyJ. J. Inglis
© 2021 The Authors
  • This is an open-access article distributed under the terms of the Creative Commons Attribution License. This article was made open access via a Publish and Read agreement between the Microbiology Society and the corresponding author’s institution.
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2021-04-15
2024-04-25
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Development, deployment and in-field demonstration of mobile coronavirus SARS-CoV-2 Nucleic acid amplification test
J. Med. Microbiol. 70, 001346 (2021); https://doi.org/10.1099/jmm.0.001346
/content/journal/jmm/10.1099/jmm.0.001346
/content/journal/jmm/10.1099/jmm.0.001346
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