Low Clinical Performance of "Isopollo COVID19 detection kit" (Monitor, South Korea) for RT-LAMP SARS-CoV-2 diagnosis: a call for action against low quality products for developing countries

Freire-Paspuel, Byron; Garcia-Bereguiain, Miguel Angel

Background Multiple molecular kits are available for SARS-CoV-2 diagnosis worldwide, lot of them lacking of proper clinical evaluation due to the emergency caused by COVID-19 pandemic, particularly at developing countries. Objective We evaluated the clinical performance of "Isopollo COVID19 detection kit" (Monitor, South Korea) for RT-LAMP SARS-CoV-2 diagnosis using SARS-CoV-2 RT-PCR protocol as a gold standard. Results 220 clinical samples were included on the study; 168 samples were SARS-CoV-2 positive and 52 samples were SARS-CoV-2 negative according to SARS-CoV-2 RT-PCR protocol. For "Isopollo COVID19 detection kit', only 104 out of 168 samples were SARS-CoV-2 positive. This result shows a low clinical performance with sensitivity of 61.9% for the evaluated RT-LAMP assay. Conclusions Proper clinical performance evaluation studies from regulatory agencies at developing countries like Ecuador should be mandatory prior to clinical use authorization of SARS-CoV-2 diagnosis kits, particularly when those kits lack of either FDA or country of origin clinical use authorization