SARS-CoV-2 Validation Testing Efforts Updated
Mar 24 2020 Read 1003 Times
Luminex Corporation has announced that four independent clinical laboratories have validated laboratory developed tests (LDTs) for automated, rapid detection of the SARS-CoV-2 virus using the sample-to-answer ARIES® System. These LDTs demonstrate that high complexity laboratories using the ARIES® System can immediately add novel coronavirus diagnostics to their testing menu. This will be important for helping to address soaring demand for coronavirus tests and will allow laboratories to produce results in approximately two hours.
Studies to verify the test parameters with contrived samples on the ARIES® System were conducted by Baylor Scott and White Health (Temple, TX), Montefiore Medical Center (Bronx, NY), Geisinger (Danville, PA), and the University of Louisville (Louisville, KY).
"As part of our broader work to make a difference in the battle against the coronavirus pandemic, Luminex is supporting laboratories in their efforts to detect and diagnose cases of COVID-19," said Nachum "Homi" Shamir, President and CEO of Luminex. "Independent validation of LDTs on our ARIES® System will help labs to quickly meet the high demand for testing around the world. We are honoured that these clinical labs have chosen to develop their coronavirus tests using our ARIES® platform and are pleased that this work can be easily reproduced at the hundreds of labs currently using the ARIES® System."
Along with these validation studies, labs across Europe and the United States are in the process of going live with their LDTs using the ARIES® System, and Luminex intends to submit an EUA for an ARIES® SARS-CoV-2 Assay next month. The platform uses real-time PCR technology that, when combined with its ability to run LDTs, is ideally suited for facilities that need to develop their own lab-specific testing for which there is no commercially available, FDA-cleared assay. The system provides the flexibility to handle STAT or batch testing and is capable of running different assays simultaneously.
Luminex has also launched and begun shipping its NxTAG® CoV Extended Panel (RUO), a unique multiplex panel that addresses the coronavirus pandemic using its existing bead-based NxTAG Technology. A number of labs in the Far East, Europe and North America have already validated this panel and are planning to go live with it this week. In addition, Luminex is planning to submit an EUA for this panel to the FDA by the end of this month.
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