A rapid, accurate, scalable, and portable testing system for COVID-19 diagnosis

Nat Commun. 2021 May 18;12(1):2905. doi: 10.1038/s41467-021-23185-x.

Abstract

The need for rapid, accurate, and scalable testing systems for COVID-19 diagnosis is clear and urgent. Here, we report a rapid Scalable and Portable Testing (SPOT) system consisting of a rapid, highly sensitive, and accurate assay and a battery-powered portable device for COVID-19 diagnosis. The SPOT assay comprises a one-pot reverse transcriptase-loop-mediated isothermal amplification (RT-LAMP) followed by PfAgo-based target sequence detection. It is capable of detecting the N gene and E gene in a multiplexed reaction with the limit of detection (LoD) of 0.44 copies/μL and 1.09 copies/μL, respectively, in SARS-CoV-2 virus-spiked saliva samples within 30 min. Moreover, the SPOT system is used to analyze 104 clinical saliva samples and identified 28/30 (93.3% sensitivity) SARS-CoV-2 positive samples (100% sensitivity if LoD is considered) and 73/74 (98.6% specificity) SARS-CoV-2 negative samples. This combination of speed, accuracy, sensitivity, and portability will enable high-volume, low-cost access to areas in need of urgent COVID-19 testing capabilities.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19 / diagnosis*
  • COVID-19 Nucleic Acid Testing* / instrumentation
  • Equipment Design
  • Genes, Viral / genetics
  • Humans
  • Limit of Detection
  • Molecular Diagnostic Techniques
  • Nucleic Acid Amplification Techniques
  • Point-of-Care Systems*
  • RNA, Viral / genetics
  • SARS-CoV-2 / genetics
  • SARS-CoV-2 / isolation & purification*
  • Saliva / virology
  • Sensitivity and Specificity

Substances

  • RNA, Viral

Supplementary concepts

  • LAMP assay