Development, deployment and in-field demonstration of mobile coronavirus SARS-CoV-2 Nucleic acid amplification test.
J Med Microbiol
; 70(4)2021 Apr.
Article
em En
| MEDLINE
| ID: mdl-33856292
ABSTRACT
Introduction. 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.Gap Statement. 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.Methodology. 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).Results The 95 and 99% limits of detection were 1.01 copies µl-1 (5.05 copies per reaction) and 2.80 copies µl-1 (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.Conclusion. 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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Teste de Ácido Nucleico para COVID-19
/
SARS-CoV-2
/
COVID-19
/
Unidades Móveis de Saúde
Tipo de estudo:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
/
Qualitative_research
Limite:
Humans
País/Região como assunto:
Oceania
Idioma:
En
Revista:
J Med Microbiol
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Austrália