Public Health Emergency - Leading a Nation Prepared
BARDA has partnered again with Luminex Corporation, this time on the development of a COVID-19 sample-to-answer diagnostic. The test detects the presence of COVID-19 in nasal and throat swabs and can be performed in community hospitals and other facilities with access to medium-complexity laboratories, thereby greatly increasing the number of tests that can be run. BARDA will contribute approximately $642,000 of the total $1.7 million estimated project cost, and Luminex will fund the remaining development costs.
Luminex has designed an assay that runs on its FDA-cleared ARIES® molecular diagnostic system for presence of COVID-19 by detecting the virus in respiratory swabs. The ARIES System is Luminex’s sample-to-answer, six-color, real-time PCR instrument. ARIES assays require little training, take less than five minutes of hands-on time, and produce results in about two hours.
The Luminex solution consists of the ARIES® System and up to six cassettes. Each assay cassette contains all the reagents needed for nucleic acid extraction, amplification and detection for one sample. An operator adds the sample, in this case, a respiratory swab, to the cassette’s sample chamber, scans the sample ID and cassette, puts up to six cassettes in a magazine, and loads the magazine into the ARIES® System. The system starts automatically and reports results without further operator intervention. The Luminex ARIES® SARS-CoV-2 assay detects via PCR, two SARS-CoV-2 targets within the “N” gene, for improved accuracy.
This is the second Luminex diagnostic to be supported by BARDA. The first was Luminex’s NxTAG® CoV Extended Panel which received FDA Emergency Use Authorization on March 27, 2020.
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