Evaluation of the analytical performance of the 15-minute point-of-care DASH™ SARS-CoV-2 RT-qPCR test

Matthew A. Butzler, Jennifer L. Reed, Kirsten M. Knapton, Tania Afzal, Abhishek K. Agarwal, Jakob Schaeffer, Neeraj Saraiya, Lisa Oti, Ezekiel R. White, Emilie Giacobbe, Lacy M. Simons, Egon Anderson Ozer, Sally M. McFall*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Accurate and timely diagnosis for COVID-19 diagnosis allows highly effective antiviral medications to be prescribed. The DASH™ Rapid PCR System is a sample-to-answer point-of-care platform combining state-of-the-art PCR kinetics with sequence specific hybridization. The platform's first assay, the DASH™ SARS-CoV-2/S test for anterior nares direct swab specimens, received FDA Emergency Use Authorization in March 2022 for point-of-care use. Here we report the analytical characteristics of the assay including limit of detection, dynamic range, and robustness of SARS-CoV-2 variant detection. The limit of detection was determined by testing swabs contrived with one hundred copies of wild type or Omicron BA.5 virus and detecting 20/20 and 19/20, respectively. The dynamic range was assessed with contrived swabs containing 102-106 copies; the log-linear relationship between Cq and copy input was plotted, and the qPCR efficiency calculated from the slope of the line was 101.4%. Detection of seven SARS-CoV-2 variants was demonstrated.

Original languageEnglish (US)
Article number116120
JournalDiagnostic Microbiology and Infectious Disease
Volume108
Issue number1
DOIs
StatePublished - Jan 2024

Keywords

  • COVID-19
  • Diagnosis
  • Point-of-Care
  • Quantitative PCR

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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