COVID-19 test kit ARIES®

SARS-COV-2coronavirusnasopharyngeal

For targeted coronavirus testing in moderate-complexity labs The ARIES® SARS-CoV-2 Assay is a real time RT-PCR-based in vitro diagnostic test that qualitatively detects SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) samples in UTM™, Liquid Amies (ESwab™), or equivalent. The ARIES® SARS‑CoV‑2 Assay (CE-IVD) offers: Fully Integrated Testing: Automate all aspects of testing, from sample preparation through analysis, in a self-contained cassette. Flexible Throughput: In two hours, process from 1 to 12 tests per batch; both STAT testing and medium volume sample batching are supported. A Versatile Portfolio: With a growing portfolio of cassette-ready assays and the tools to create laboratory developed tests (LDTs),* ARIES® Systems deliver reliable detection for a wide range of testing needs. Reliable Performance: In addition to sensitive detection of SARS-CoV-2 through the ORF1ab and N gene targets, a sample processing control included in the cassette confirms result validity. Performance A limit of detection (LoD) study was performed to evaluate the analytical sensitivity of the ARIES® SARS-CoV-2 Assay using one strain of SARS-CoV-2, isolate USA-WA1/2020. The confirmed ARIES SARS-CoV-2 Assay LoD concentration is 3.00 x 103 GCE/mL. Workflow Step 1 Load the sample into the cassette. Step 2 Insert up to six cassettes into the magazine. Step 3 Insert one or both magazines into the instrument. Step 4 Review & release results.