Evaluation of a near-patient SARS-CoV-2 novel rapid diagnostic platform
The goal of this study is to test a novel device and methodology based on the "Pebble" platform and real-time quantitative colorimetric loop-mediated isothermal amplification (qcLAMP) during SARS-CoV-2 detection using crude samples and extracted RNA. The new method employs an inexpensive lightweight device aimed toward rapid point-of-care testing. An extensive evaluation was performed consisting of 1,693 clinical samples across five independent clinical testing centers. Positive colorimetric results were observed within 20 minutes of testing. At a 20-minute time-to-positive cut-off, the specificity is 98.5% with a diagnostic accuracy of 91.9%, compared to qPCR assays. Our findings indicate that the SARS-CoV-2 qcLAMP diagnostic assay in conjunction with the Pebble device is ideal for point-of-care/near-patient testing.IMPORTANCEHere, we describe our analyses and validation of a novel real-time quantitative colorimetric loop-mediated isothermal amplification (qcLAMP) device, available under the name "Pebble" and associated SARS-CoV-2 diagnostic qcLAMP assay for clinical diagnostic use. The analyses were performed in five independent testing sites across Europe using clinical samples from the associated clinical sites and support the use of "pebble" and associated kit in the diagnostic environment.
Authors
- Nicolas Yin (ORCID: https://orcid.org/0000-0003-1706-6869)
- George Papadakis (ORCID: https://orcid.org/0000-0001-5964-6568)
- V. Tsiakalou
- Olivier Vandenberg (ORCID: https://orcid.org/0000-0003-0484-4502)
- Johannes C. Botha (ORCID: https://orcid.org/0000-0002-7635-7810)
- Eleni Nastouli (ORCID: https://orcid.org/0000-0002-1684-2013)
- Lemonia Skoura (ORCID: https://orcid.org/0000-0001-9665-1286)
- Moira J. Spyer (ORCID: https://orcid.org/0000-0001-9149-6029)
- Anne‐Geneviève Marcelin (ORCID: https://orcid.org/0000-0003-4808-8999)
- George Sourvinos (ORCID: https://orcid.org/0000-0002-9297-4288)
- Karen Zafilaza (ORCID: https://orcid.org/0009-0000-2071-9395)
- Electra Gizeli (ORCID: https://orcid.org/0000-0002-3598-5984)
- S. Chatziioannidou
- Sofia Balaska (ORCID: https://orcid.org/0000-0002-6925-8128)
- Alexandros Zafiropoulos (ORCID: https://orcid.org/0000-0002-8042-9899)
- Cathia Soulié (ORCID: https://orcid.org/0009-0008-2032-4148)
Institutions
- Université Libre de Bruxelles (BE)
- University College London Hospitals NHS Foundation Trust (GB)
- University of Crete (GR)
- Inserm (FR)
- Aristotle University of Thessaloniki (GR)
- AHEPA University Hospital (GR)
- Sorbonne Université (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Science and Technology Park of Crete (GR)
- Institut Pierre Louis d‘Épidémiologie et de Santé Publique (FR)
- Institute of Molecular Biology and Biotechnology (BG)
- Institute of Infection and Immunity (CA)
- University College London (GB)
- Foundation for Research and Technology Hellas (GR)
Publication Details
- Journal
- Microbiology Spectrum
- Published
- 2024-10-18
- DOI
- https://doi.org/10.1128/spectrum.00672-24
- Citations
- 1
- Primary Topic
- Biosensors and Analytical Detection
- Type
- article
- Field-Weighted Citation Impact
- 0.18
Funders
- Horizon 2020 Framework Programme