SEOUL, Korea, April 22, 2020 – SML Genetree has obtained CE-IVD (In Vitro Diagnostics) from the European Commission, allowing the use of SML Genetrees Ezplex® SARS-CoV-2 G Kit in the EU markets.
Medical devices in the EU undergo a conformity assessment, demonstrating legal requirements, and ensuring safety. A CE (Conformité Européenne) mark is received upon the passing of all standards. SML Genetrees Ezplex® SARS-CoV-2 G Kit utilizes an innovative multiplex, real-time polymerase chain reaction (PCR), detecting 2 target genetics (RdRp, N). Automated analysis systems enable throughput at scale.
SMLGenetrees Ezplex® SARS-CoV-2 G Kit has proven to deliver 100% sensitivity and 100% specificity in tests administered by Korean and Japanese laboratories. Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate), whereas test specificity is the ability of the test to correctly identify those without the disease (true negative rate).
Original article: Korean Business News
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