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

Objective: 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 identify robustness a colorimetric RT-LAMP assay kit that we developed, detecting SARS-COV-2 viral RNA within 30 minutes using primer set special N gene against RT-PCR, gold standard. Materials Methods: Both symptomatic asymptomatic subjects were included from single university hospital status both RT-PCR results compared, consistency these two assays was analyzed. Results: We showed confirmed 90% consistency. When consider epidemiologic, clinical, radiologic evaluation, reached 97%. Conclusion: The revealed efficient, robust, rapid be used as in vitro diagnostic tool display competitiveness compared with RT-PCR. Keywords: RT-LAMP, COVID-19, PCR, detection kit, gene,