Genetron Receives FDA Emergency Use Authorization for SARS-CoV-2 RNA Test

By LabMedica International staff writers
Posted on 09 Jun 2020

Genetron Health (Beijing, China) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration for the company’s independently developed detection kit for the novel coronavirus.

The company’s new Genetron SARS-CoV-2 RNA Test kit has also received approval for export from the relevant authorities in China as well as obtained CE marking. Genetron SARS-CoV-2 RNA Test is an accurate, fast, contamination-free testing solution, which efficiently detects large-scale samples for the novel coronavirus. It detects two different and highly specific gene sequences of SARS-CoV-2: ORF1ab and N, which improves both its accuracy and specificity. It also includes an internal reference to prevent possible false negative results. Each test is capable of detecting SARS-CoV-2 RNA as low as 10 copies.

Image: Genetron SARS-CoV-2 RNA Test (Photo courtesy of Genetron Health)

Using patented technology, the One-Step Seq Method, the process integrates reverse transcription of viral RNA and quantitative PCR reaction in a single step. The entire process takes less than 2.5 hours, including only 10 minutes of hands-on time. Additionally, the application of contamination resistant dUTP and UDG enzymes allows the system to degrade non-specific and nucleic acid-contaminated PCR products.

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