Evaluation of a SARS-CoV-2 lateral flow assay using the plaque reduction neutralization test

Xuping Xie, Marisa C. Nielsen, Antonio E. Muruato, Camila R. Fontes-Garfias, Ping Ren

Research output: Contribution to journalArticlepeer-review

12 Scopus citations


As new tests and technologies advance our understanding and diagnostic capabilities of the severe acute respiratory syndrome coronavirus 2 and the coronavirus disease 2019, they must be appropriately validated to make sure test performance is following manufacturer claims. In this study, we evaluated the Vazyme 2019-nCoV IgG/IgM Detection Kit, which is a lateral flow assay (LFA), by the plaque reduction neutralization test (PRNT) using 100 patient plasma/serum samples. As compared to the PRNT results, the Vazyme LFA had 95.9% sensitivity and 96.1% specificity. Along with the increased need for rapid, effective, and affordable point of care tests to help provide meaningful epidemiological data, we demonstrated that the Vazyme LFA performed well on IgG detection but cannot be judged on the performance of IgM detection using PRNT alone. However, our observation of the low IgM-positive rate supported the poor performance of IgM detection of this LFA which led to the disapproval of its Emergency Use Authorization recently.

Original languageEnglish (US)
Article number115248
JournalDiagnostic Microbiology and Infectious Disease
Issue number2
StatePublished - Feb 2021


  • IgG
  • IgM
  • SARS-CoV-2
  • lateral flow assay
  • plaque reduction neutralization test

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases


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