Clinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays

PLoS One. 2021 Aug 17;16(8):e0256352. doi: 10.1371/journal.pone.0256352. eCollection 2021.

Abstract

Rapid tests for SARS-COV-2 infection are important tools for pandemic control, but current rapid tests are based on proprietary designs and reagents. We report clinical validation results of an open-access lateral flow assay (OA-LFA) design using commercially available materials and reagents, along with RT-qPCR and commercially available comparators (BinaxNOW® and Sofia®). Adult patients with suspected COVID-19 based on clinical signs and symptoms, and with symptoms ≤7 days duration, underwent anterior nares (AN) sampling for the OA-LFA, Sofia®, BinaxNOW ™, and RT-qPCR, along with nasopharyngeal (NP) RT-qPCR. Results indicate a positive predictive agreement with NP sampling as 69% (60% -78%) OA-LFA, 74% (64% - 82%) Sofia®, and 82% (73% - 88%) BinaxNOW™. The implication for these results is that we provide an open-access LFA design that meets the minimum WHO target product profile for a rapid test, that virtually any diagnostic manufacturer could produce.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antigens, Viral / analysis*
  • Area Under Curve
  • COVID-19 / diagnosis*
  • COVID-19 / virology
  • Humans
  • Immunoassay*
  • Nasopharynx / virology
  • Point-of-Care Systems
  • RNA, Viral / analysis
  • RNA, Viral / metabolism
  • ROC Curve
  • Real-Time Polymerase Chain Reaction
  • SARS-CoV-2 / isolation & purification
  • SARS-CoV-2 / metabolism*
  • Sensitivity and Specificity

Substances

  • Antigens, Viral
  • RNA, Viral

Grants and funding

All Authors of the manuscript work for the funding organization - Global Health Labs. https://www.ghlabs.org/.