Although the reverse transcription-polymerase chain reaction (RT-PCR) is considered a standard-of-care assay for the laboratory diagnosis of SARS-CoV-2, several limitations of this method have been described. Reverse transcription loop-mediated isothermal amplification (RT-LAMP) is an alternative molecular assay and is potentially able to overcome some intrinsic shortcomings of RT-PCR. In this study, we evaluated the diagnostic performance of the novel HG COVID-19 RT-LAMP assay. In this retrospective analysis, a total of 400 routinely collected leftover nasopharyngeal samples with a known RT-PCR result were tested by means of the HG COVID-19 RT-LAMP assay. The overall sensitivity and specificity values of HG COVID-19 RT-LAMP versus RT-PCR were 97.0% (95% CI: 93.6–98.9%) and 98.5% (95% CI: 95.7–99.7%), respectively. Inter-assay agreement was almost perfect ( κ = 0.96). Concordance was perfect in samples with high viral loads (cycle threshold < 30). The average time to a positive result on RT-LAMP was 17 min. HG COVID-19 RT-LAMP is a reliable molecular diagnostic kit for detecting SARS-CoV-2, and its performance is comparable to that of RT-PCR. Shorter turnaround times and the possibility of performing molecular diagnostics in the point-of-care setting make it a valuable option for facilities without sophisticated laboratory equipment.
【저자키워드】 COVID-19, SARS-CoV-2, RT-PCR, RT-LAMP, Diagnostic accuracy, 【초록키워드】 equipment, Transcription, diagnostic, diagnostics, Laboratory, point-of-care, Sensitivity and specificity, Viral load, cycle threshold, Retrospective analysis, isothermal amplification, molecular, turnaround time, positive result, average, Standard-of-care, nasopharyngeal sample, intrinsic, tested, described, collected, evaluated, overcome, comparable, diagnosis of SARS-CoV-2, several limitation, 【제목키워드】 detection, Rapid, novel, performance, Comparative,