Performances of rapid and connected salivary RT-LAMP diagnostic test for SARS-CoV-2 infection in ambulatory screening

Sci Rep. 2022 Feb 18;12(1):2843. doi: 10.1038/s41598-022-04826-7.

Abstract

In the context of social events reopening and economic relaunch, sanitary surveillance of SARS-CoV-2 infection is still required. Here, we evaluated the diagnostic performances of a rapid, extraction-free and connected reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assay on saliva. Nasopharyngeal (NP) swabs and saliva from 443 outpatients were collected simultaneously and tested by reverse-transcription quantitative PCR (RT-qPCR) as reference standard test. Seventy-one individuals (16.0%) were positive by NP and/or salivary RT-qPCR. Sensitivity and specificity of salivary RT-LAMP were 85.9% (95%CI 77.8-94.0%) and 99.5% (98.7-100%), respectively. Performances were similar for symptomatic and asymptomatic participants. Moreover, SARS-CoV-2 genetic variants were analyzed and no dominant mutation in RT-LAMP primer region was observed during the period of the study. We demonstrated that this RT-LAMP test on self-collected saliva is reliable for SARS-CoV-2 detection. This simple connected test with optional automatic results transfer to health authorities is unique and opens the way to secure professional and social events in actual context of economics restart.

Publication types

  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Asymptomatic Infections
  • COVID-19 Nucleic Acid Testing / statistics & numerical data*
  • Female
  • Humans
  • Male
  • Mass Screening
  • Middle Aged
  • Molecular Diagnostic Techniques / statistics & numerical data*
  • Nucleic Acid Amplification Techniques / statistics & numerical data*
  • SARS-CoV-2 / isolation & purification*
  • Saliva / virology*
  • Viral Load
  • Young Adult

Supplementary concepts

  • LAMP assay