Laboratory Evaluation of a SARS-CoV-2 RT-LAMP Test

Abstract

There is a need to have more accessible molecular diagnostic tests for the diagnosis of severe acute respiratory syndrome coronavirus 2 disease in low- and middle-income countries. Reverse transcription loop-mediated isothermal amplification (RT-LAMP) may provide an attractive option as this technology does not require a complex infrastructure. In this study, the diagnostic performance of a SARS-CoV-2 RT-LAMP was evaluated using RT-PCR-confirmed clinical specimens of COVID-19-positive (n = 55) and -negative patients (n = 55) from the Netherlands. The observed sensitivity of the RT-LAMP test was 97.2% (95% CI: 82.4–98.0%) and the specificity was 100% (95% CI: 93.5–100%). The positive predictive value of the RT-LAMP was 100%, the negative predictive value 93.2% (95% CI: 84.3–97.3%), and the diagnostic accuracy was 96.4% (95% CI: 91.0–99.0%). The agreement between the RT-LAMP and the RT-PCR was “almost perfect” (κ-value: 0.92). The evaluated RT-LAMP might provide an attractive alternative molecular diagnostic tool for SARS-CoV-2 in resource limited settings.