The ARIES SARS‑CoV‑2 Assay (EUA) is a real-time PCR-based in vitro diagnostic test that detects SARS‑CoV‑2 nucleic acid in nasopharyngeal swab (NPS) samples. Using the sample-to-answer ARIES System, the ARIES SARS‑CoV‑2 Assay delivers sensitive, rapid results in about two hours.
The ARIES SARS‑CoV‑2 Assay (EUA) offers:
- Precise Results: A sample-to-answer test that enables targeted SARS‑CoV‑2 detection.
- Fast Turnaround Time: Minimal hands-on time and an automated workflow deliver results in about two hours.
- Robust Detection: Exonuclease-sensitive probes for the ORF1ab and N viral genes provide superior specificity.
Performance
The performance of the ARIES SARS‑CoV‑2 Assay was evaluated using blinded and randomized clinical specimens. The results are summarized in the table below.
*A mean Ct was calculated for the specimens where Ct was available.
†Several replicates were negative for the ORF1ab gene, however, the N gene target was detected for these replicates, and the specimens were assigned a positive result.
‡An additional 30 contrived clinical positives and 30 clinical negative specimens were tested using purified SARS-CoV-2 viral genomic RNA (USA_WA1/2020 strain) obtained from World Reference Center for Emerging Viruses and Arboviruses (WRCEVA), and there were no changes to the assay performance between the old data and the new.