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The company's approach relies on an initial point-of-care lateral flow assay followed by a confirmatory real-time PCR analysis run in its laboratories.
The test, run on the BD Max system, allows hospitals to diagnose SARS-CoV-2 on site and receive results in less than three hours.
Bringing testing closer to patients could be helpful, provided enough tests and instruments can be manufactured and distributed.
The AvellinoCoV2 real-time PCR test is designed for the detection of nucleic acid from SARS-CoV-2 from nasopharyngeal and oropharyngeal swab specimens.
Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.
The test from Singapore-based Credo requires minimal training to run and can detect pathogens in 20 minutes, with about one minute of hands-on time.
The test, authorized March 13, runs on the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument and targets three regions of the SARS-CoV-2 genome.
The test is the third to receive EUA, following tests from the CDC and New York state, and it runs on Roche's Cobas 6800 and 8800 systems.
Technology partners on the study include BioMérieux and SkylineDx, as well as Imperial College London's biomedical electronics unit.
Directing lab-developed tests through the emergency use authorization process has brought to light reagent supply shortages and other hurdles.