Performance of the RT-LAMP-based eazyplex® SARS-CoV-2 as a novel rapid diagnostic test.

Abstract Background Diagnostic assays for severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) that are easy to perform and produce fast results are essential for timely decision making regarding the isolation of contagious individuals. Objective We evaluated the CE-approved eazyplex® SARS-CoV-2, a ready-to-use real time RT-LAMP assay for identification of the SARS-CoV-2 N and ORF8 genes from swabs in less than 30 min without RNA extraction. Study design Oropharyngeal and nasal swabs from 100 positive and 50 negative patients were inoculated into 0.9% saline and tested by NeuMoDx™ RT-PCR. An aliquot was diluted fivefold in Copan sputum liquefying (SL) solution and directly analyzed by eazyplex® SARS-CoV-2. In addition, 130 patient swabs were prospectively tested with both methods in parallel. Analytical sensitivity of the assay was determined using virus stock dilutions. Results Positive percent agreement (PPA) between the eazyplex® SARS-CoV-2 and RT-PCR was 74% for samples with Ct values Conclusion The eazyplex® SARS-CoV-2 is a rapid assay that accurately identifies samples with high viral loads. It may be useful for near-patient testing outside of a molecular diagnostic laboratory.