Published November 18, 2022 | Version v1
Journal article Open

Accurate Diagnosis of COVID-19 from Self-Collectable Biospecimens Using Synthetic Apolipoprotein H Peptide-Coated Nanoparticle Assay

  • 1. Copernicus Integrated Solutions for Biosafety Risks (CISBR), Mauguio 34130, France; ApoHTechnologies, La Grande Motte 34280, France; UMR5151/ French Research Institute for Development (IRD), University of Montpellier (UM), Montpellier 34093, France
  • 2. Department of Internal Medicine, Seoul National University College of Medicine, Seoul 03080, Korea
  • 3. Interdisciplinary Program in Bioengineering, Seoul National University, Seoul 08826, Korea; Bio-MAX Institute and Department of Electrical and Computer Engineering, Seoul National University, Seoul 08826, Korea; QuantaMatrix Inc., Seoul 08506, Korea; Biomedical Research Institute, Seoul National University Hospital, Seoul 03080, Korea
  • 4. Interdisciplinary Program in Bioengineering, Seoul National University, Seoul 08826, Korea; Integrated Major in Innovative Medical Science, Seoul National University, Seoul 03080, Korea
  • 5. Interdisciplinary Program in Bioengineering, Seoul National University, Seoul 08826, Korea
  • 6. Bio-MAX Institute and Department of Electrical and Computer Engineering, Seoul National University, Seoul 08826, Korea
  • 7. QuantaMatrix Inc., Seoul 08506, Korea; Interdisciplinary Program in Cancer Biology, Seoul National University College of Medicine, Seoul 03080, Korea
  • 8. QuantaMatrix Inc., Seoul 08506, Korea
  • 9. Department of Electrical and Computer Engineering, Seoul National University, Seoul 08826, Korea
  • 10. International Vaccine Institute, Seoul 08826, Korea

Description

A high-throughput, accurate screening is crucial for
the prevention and control of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2). Current methods, which involve
sampling from the nasopharyngeal (NP) area by medical staffs,
constitute a fundamental bottleneck in expanding the testing
capacity. To meet the scales required for population-level
surveillance, self-collectable specimens can be used; however, its
low viral load has hindered its clinical adoption. Here, we describe a
magnetic nanoparticle functionalized with synthetic apolipoprotein
H (ApoH) peptides to capture, concentrate, and purify viruses. The
ApoH assay demonstrates a viral enrichment efficiency of >90% for
both SARS-CoV-2 and its variants, leading to an order of magnitude
improvement in analytical sensitivity. For validation, we apply the
assay to a total of 84 clinical specimens including nasal, oral, and mouth gargles obtained from COVID-19 patients. As a result, a
100% positivity rate is achieved from the patient-collected nasal and gargle samples, which exceeds that of the traditional NP swab
method. The simple 12 min pre-enrichment assay enabling the use of self-collectable samples will be a practical solution to overcome
the overwhelming diagnostic capacity. Furthermore, the methodology can easily be built on various clinical protocols, allowing its
broad applicability to various disease diagnoses.

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Additional details

Funding

European Commission
EPIC-CROWN-2 – Equine Polyclonal antibodies Immunotherapy against COVID-19/SARS-CoV2–VOC 101046084