The UltraGene® Combo2Screen SARS-CoV-2 Assay is a real-time RT-PCR nucleic acid technique intended to be used for the qualitative detection of nucleic acids from patients with acute respiratory syndrome-associated coronavirus 2 (SARS-CoV2) and directed against the E and N genes of SARS-CoV-2 virus.
Dual target assay, with specific targets unique to SARS-Cov-2 (COVID-19 Coronavirus) and directed against the E and N genes.
Specificity: 100% in clinical evaluations (95% CI: 84.56%-100%)
Sensitivity: 100% in clinical evaluations (95% CI: 84.56%-100%)
Clinical Reproducibility: 100% obtained via QCMD 2020 Coronavirus Outbreak Preparedness EQA reference study (Ref# QAV204214_1)
Compatible with main standard qPCR platforms
Simple workflow / estimated turnaround time 1 hour 45 minutes
Standard throughput per platform between 300-500 samples per shift