Abstract
Background: Multiple molecular kits are available for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) worldwide, with many lacking proper clinical evaluation due to the emergency caused by the coronavirus disease 2019 (COVID-19) pandemic, particularly in developing countries.
Methods: This study was conducted to evaluate the clinical performance of the Isopollo COVID-19 detection kit (M Monitor, South Korea) for reverse transcription loop-mediated isothermal amplification (RT-LAMP) SARS-CoV-2 diagnosis, using the SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) protocol as the gold standard.
Results: A total of 220 clinical samples were included in the study; 168 samples were SARS-CoV-2-positive and 52 samples were SARS-CoV-2-negative according to the SARS-CoV-2 RT-PCR protocol. For the Isopollo COVID-19 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 by regulatory agencies in developing countries such as Ecuador should be mandatory prior to clinical use authorization of SARS-CoV-2 diagnosis kits, particularly when those kits lack either US Food and Drug Administration or country of origin clinical use authorization.
Keywords: Isopollo COVID-19; RT-LAMP; RT-PCR; SARS-CoV-2.
【저자키워드】 SARS-CoV-2, RT-PCR, RT-LAMP, Isopollo COVID-19, 【초록키워드】 COVID-19, coronavirus disease, SARS-CoV-2, Coronavirus disease 2019, coronavirus, pandemic, protocol, Diagnosis, drug, severe acute respiratory syndrome Coronavirus, RT-PCR, reverse transcription polymerase chain reaction, polymerase chain reaction, clinical samples, RT-LAMP, sensitivity, Loop-mediated isothermal amplification, clinical evaluation, gold, reverse transcription, isothermal amplification, Ecuador, molecular, South Korea, food, Emergency, Chain Reaction, Clinical use, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, gold standard, Drug administration, regulatory agencies, Multiple, country, regulatory agency, polymerase chain, clinical sample, lack, evaluate, caused, evaluated, conducted, mandatory, the SARS-CoV-2, 【제목키워드】 COVID-19, SARS-CoV-2, country,