Clinical Validation and Evaluation of a Colorimetric SARS-CoV-2 RT-LAMP Assay Against RT-PCR.

Abstract

Reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) is one of the time-saving, accurate, and cost-effective alternative methods to real-time polymerase chain reaction (RT-PCR). This study aimed to identify the robustness of a colorimetric RT-LAMP assay kit that we developed, detecting SARS-COV-2 viral RNA within 30 minutes using a primer set special to the N gene against RT-PCR, the gold standard. Both symptomatic and asymptomatic subjects were included from a single university hospital and the status of both RT-PCR and RT-LAMP assay results were compared, and the consistency of these two assays was analyzed. We showed that the RT-LAMP and RT-PCR assay results confirmed 90% consistency. When we consider the epidemiologic, clinical, and radiologic evaluation, the consistency reached 97%. The results revealed that the colorimetric RT-LAMP assay was efficient, robust, and rapid to be used as in vitro diagnostic tool to display competitiveness compared with RT-PCR.