KimForest Receives FDA EUA for COVID-19 Detection

KimForest Receives FDA EUA for COVID-19 Detection

On the 21st of September 2020, we received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for the KimForest SARS-CoV-2 detection kit. The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. An IVD made available under a EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue a EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19. The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used). The KimForest SARS-CoV-2 detection kit was one of the earlier detection kits that used RT-PCR (Reverse Transcription Polymerase Chain Reaction) that was issued a EUA.

KimForest SARS-CoV-2 Detection Kit has been optimized to shorten the procedures to 100 minutes, which is much more efficient than the existing tests that take three to four hours. Our detection kit also is designed to handle the different mutations of the SARS-CoV-2 virus strains across Europe, the Americas, and Asia, which reduce the possibility of a false negative result. The KimForest SARS-CoV-2 Detection Kit also provides an instrument that would minimize manual inputs and reduce uncertainties in detection procedures. The KimForest SARS-CoV-2 Detection Kit has high sensitivity and high specificity, which means that any variant of SARS-CoV-2 is detected by the kit and that there is no cross-reactivity with common respiratory flora and other viral pathogens.

Not only has the KimForest SARS-CoV-2 Detection Kit received the prestigious EUA from the United States FDA, but it has also received numerous other certifications and licenses. The certifications of the KimForest SARS-CoV-2 Detection Kit include but is not limited to TFDA (Taiwan Food and Drug Administration) Production and Export Certificate, Certificate of Origin, US FDA EUA Manufacturer Certificate, US FDA EUA Laboratories Notification – PacGenomics, US FDA EUA Laboratories Notification – Sun Clinical Lab, Republic of Philippines FDA Certificate, CE EAR (European Authorized Representative) Certificate, CE Notification.

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