A magnetic modulation biosensing-based molecular assay for rapid and highly sensitive clinical diagnosis of COVID-19

Michael Margulis, Oran Erster, Shira Roth, Michal Mandelboim, Amos Danielli

Research output: Chapter in Book/Report/Conference proceedingConference contributionpeer-review

Abstract

The COVID-19 pandemic demands fast, sensitive, and specific diagnostic tools for virus surveillance and containment. Current methods for diagnosing the COVID-19 are based on direct detection of either viral antigens or viral ribonucleic acids (RNA) in swab samples. Antigen-targeting tests are simple, have fast turnaround times, and allow rapid testing. Unfortunately, compared with viral RNA-targeting tests, their sensitivity is low, especially during the initial stages of the disease, which limits their adoption and implementation. Direct detection of SARS-CoV-2 RNA using reversetranscription quantitative polymerase chain reaction (RT-qPCR) is sensitive and specific, making it a golden standard in SARS-CoV-2 detection. However, it had not seen a significant update since its introduction three decades ago. It has a long turnaround time, requires a high number of amplification cycles, and a complicated and expensive detection system for real-time monitoring of the signal. While insignificant for research applications, these limitations present severe problems for mass testing required to contain the disease. Here, we introduce a diagnostic platform for rapid and highly sensitive clinical diagnosis of COVID-19. Based on the biochemical principles of the RT-PCR, it utilizes the endpoint detection by the magnetic modulation biosensing (MMB) system, allowing the detection of as little as two copies of SARS-CoV-2 in ∼30 minutes. Testing 309 RNA samples from verified SARS-CoV-2 carriers and healthy subjects resulted in 97.8% sensitivity, 100% specificity, and 0% crossreactivity. This level of performance is on par with the gold standard (RT-qPCR) but requires 1/3 of the time. The platform can be easily adapted to detect almost any other pathogen of choice.

Original languageEnglish
Title of host publicationFrontiers in Biological Detection
Subtitle of host publicationFrom Nanosensors to Systems XIV
EditorsAmos Danielli, Benjamin L. Miller, Sharon M. Weiss, Ramesh Raghavachari, Mikhail Y. Berezin
PublisherSPIE
ISBN (Electronic)9781510648296
DOIs
StatePublished - 2022
EventFrontiers in Biological Detection: From Nanosensors to Systems XIV 2022 - Virtual, Online
Duration: 20 Feb 202224 Feb 2022

Publication series

NameProgress in Biomedical Optics and Imaging - Proceedings of SPIE
Volume11979
ISSN (Print)1605-7422

Conference

ConferenceFrontiers in Biological Detection: From Nanosensors to Systems XIV 2022
CityVirtual, Online
Period20/02/2224/02/22

Bibliographical note

Publisher Copyright:
© COPYRIGHT SPIE. Downloading of the abstract is permitted for personal use only.

Keywords

  • COVID-19
  • RT-qPCR
  • SARS-CoV-2
  • detection
  • diagnostics
  • nucleic acids amplification
  • rapid

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