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Trop Med Infect Dis . Laboratory Evaluation of a SARS-CoV-2 RT-LAMP Test

tetano

Editor, Senior Moderator
Trop Med Infect Dis


. 2023 Jun 13;8(6):320.
doi: 10.3390/tropicalmed8060320. Laboratory Evaluation of a SARS-CoV-2 RT-LAMP Test

Sandra Menting[SUP] 1 [/SUP], Annette Erhart[SUP] 2 [/SUP], Henk D F H Schallig[SUP] 1 [/SUP]



Affiliations
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.

Keywords: COVID-19; LMICs; RT-LAMP; RT-PCR; molecular diagnostic; performance.

 
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