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

Francisco Santos Schneider (1) , Laurence Molina (1) , Marie-Christine Picot , Nicolas L’helgoualch (1) , Julien Espeut (1) , Pierre Champigneux (1) , Mellis Alali (1) , Julie Baptiste (1) , Lise Cardeur (1) , Christophe Carniel , Martin Davy (1) , Daniel Dedisse , Benjamin Dubuc (1) , Hugo Fenech (1) , Vincent Foulongne (2) , Carole Fruchart Gaillard , Florence Galtier , Alain Makinson , Grégory Marin , Raissa Medina Santos , David Morquin , Alimata Ouedraogo , Alexandra Prieux Lejeune (1) , Marine Quenot (1) , Pierre Keiflin , Francisco Checa Robles (1) , Carolina Rodrigues Rego (1) , Nicolas Salvetat (1) , Charline Trento (1) , Diana Vetter (1) , Franck Molina (1) , Jacques Reynes

1 Sys2Diag - Sys2Diag-Modélisation et Ingénierie des Systèmes Complexes Biologiques pour le Diagnostic
2 PCCEI - Pathogenesis and Control of Chronic and Emerging Infections

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.

Domaines: Sciences du Vivant [q-bio]; Médecine humaine et pathologie

Francisco Santos Schneider, Laurence Molina, Marie-Christine Picot, Nicolas L’helgoualch, Julien Espeut, et al.. Performances of rapid and connected salivary RT-LAMP diagnostic test for SARS-CoV-2 infection in ambulatory screening. Scientific Reports, 2022, 12 (1), pp.2843. ⟨10.1038/s41598-022-04826-7⟩. ⟨hal-03782524⟩