Charles River guide to USP chapter 86 for bacterial endotoxin testing
 

« Previous article
Bio-Rad’s Comp...
Next article »
Abbott ID NOW™...

23rd April 2020  Editorial by: Paul Carton

COVID-19 Assay with 3 SARS-CoV-2 Targets in One Tube Receives US FDA-EUA


A high-throughput multiplex assay for SARS-CoV-2 has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). The Seegene Allplex™ 2019-nCoV Assay contains all reagents necessary to test for COVID-19 in one tube, allowing users to maximize 96-well plate runs. 

Within this single reaction tube, the assay targets three SARS-Cov-2 genes; E, RdRP and N genes, thus providing greater specificity.

Before receiving FDA-EUA, Seegene had already sold 10 million tests globally and now has the capacity to produce one million tests per week. The assay has also been approved for import by Health Canada, where the majority of tests approved have been developed in-house.

The test runs on CFX96™ and CFX96 Touch™ Real-Time PCR Detection Systems (Bio-Rad) with a limit of detection (LoD) of 1250 copies/ml and 4167 copies/ml respectively.  

Using its exclusive AI-based assay design platform, Seegene was able to rapidly develop the assay shortly after the COVID-19 outbreak started in China. Seegene's proprietary high multiplex chemistry, technology combined with its unique automated solution, has played a pivotal role in South Korea's rapid response to the COVID 19 outbreak.

Seegene anticipates that the FDA EUA approval will now enable laboratories in the United States to run the Seegene's test immediately for high-volume testing.


Share on:

Tags:


Date Published: 23rd April 2020

Source article link: View


View full company details





Puritan specimen collection devices are designed with people in mind
 

Pyrostar Neo plus recombinant endotoxin detection reagent from FUJIFILM
 

Woman smiling new products coming from MWE see us at ESCMID 2025
 

Bridging the Gap a rapidmicrobiology special focus
 

Get our eNewsletter
Over 7,000 microbiology professionals get our weekly eNewsletter - subscribe now and find out why!

LATEST MICROBIOLOGY NEWS

MICROBIOLOGY EVENTS