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?:abstract
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BACKGROUND: Several molecular kits are available for SARS-CoV-2 diagnosis, mostly lacking of proper clinical evaluation due to the emergency caused by COVID19 pandemia, particularly at developing countries like Ecuador. OBJECTIVE: We carried out an evaluation of the clinical performance of \'AccuPower SARS-CoV-2 Real Time RT-PCR kit\' (Bioneer, South Korea) for SARS-CoV-2 diagnosis using 2019-nCoV CDC EUA kit (IDT, USA) as a gold standard. RESULTS: 48 clinical specimens were included on the study, 38 tested SARS-CoV-2 positive and 10 SARS-CoV-2 negative for 2019-nCoV CDC EUA kit. For \'AccuPower SARS-CoV-2 Real Time RT-PCR kit\', only 30 were SARS-CoV-2 positive, indicating a low clinical performance with sensitivity of 78.9%. Moreover, the limit of detection for \'AccuPower SARS-CoV-2 Real Time RT-PCR kit\' was estimated to be higher than 40,000 viral RNA copies/mL of sample. CONCLUSIONS: Proper clinical performance evaluation studies from government agencies at developing countries should be mandatory prior to clinical use authorization of SARS-CoV-2 diagnosis kits, particularly when those kits lack of either FDA or its country of origin clinical use authorization, to prevent the distribution of low quality products that may have a negative impact of COVID19 surveillance at developing countries.
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