To combat the COVID-۱۹ pandemic, it is critical to quickly and accurately detect
SARS-CoV-۲ infection in patients since there are currently no effective antiviral drugs or vaccines available. This study aimed to create and evaluate a rapid
One-Step LAMP assay that can directly detect
SARS-CoV-۲ RNA from nasopharyngeal swab samples of patients suspected of having the infection in comparison with RT-qPCR assay. In this research, a crosssectional survey involved testing ۲۲۵ nasopharyngeal swab samples from patients suspected of having COVID-۱۹ using two different methods: OneStep RT-qPCR and
One-Step LAMP assay. The
One-Step LAMP assay directly amplified the extracted RNA from the
SARS-CoV-۲ nasopharyngeal sample using a new version of the key enzyme of the LAMP reaction called Bst DNA/RNA Polymerase ۳.۰ (Bst ۳). The study evaluated the accuracy and reliability of the
One-Step LAMP assay by comparing it with One-Step RTqPCR using positive and negative clinical samples of COVID-۱۹. Out of the ۲۲۵ participants, the
One-Step RT-qPCR and
One-Step LAMP assays detected positive
SARS-CoV-۲ results in ۱۱۵(۵۱.۱%) and ۱۱۰(۴۸.۸%) participants, respectively. The Cohen's kappa coefficient (κ) demonstrated that there was a ۹۷% agreement rate between the two tests, which was statistically significant (P <۰.۰۰۱), The study found a significant relationship (P <۰.۰۰۱) between the variables of residency, clinical signs of sore throat, fever and chills, shortness of breath, underlying health conditions (UHC), LICT, and infection with SARS-CoV-۲. The study concluded that the One Step LAMP assay is an effective method for detecting
SARS-CoV-۲ in suspected patients compared to the
One-Step RT-qPCR method due to its low cost, simplicity, sensitivity, and specificity. Therefore, the
One-Step LAMP assay has significant potential as a valuable diagnostic tool for disease control, timely treatment, and protecting public health during epidemics.