The State of the Art COVID-19 Diagnosis
PCR instruments
➢ Two Target Test: E gene and RdRP gene (one target per tube)
➢ High Throughput: Over 368 patients (768 assays) per 8 hours
➢ More than 200% Enhancement of RT-PCR Throughput
Ultra-Fast RT-PCR Assays with Extreme Sensitivity
➢ The Shortest RT-PCR Time: ≤ 50 min on Bio-Rad CFX96 and ABI
QuantStudio 5, and 58 min on ABI 7500 Fast (3 min for reverse
transcription, 1 min for hot start, and 1 min per cycle)
➢ Ultimate High Sensitivity: Can detect down to 5 copies/reaction of
SARS-CoV-2 with at least 95% hit rate (LoD: 8.2 copies/reaction for E
gene and 5.3 copies/reaction for RdRP gene)
❖ Assay Format and Product Components
➢ Two Assay Format: Assay 1 using Premix 1 for detecting E gene
that is common to Sarbecovirus; and Assay 2 using Premix 2 for
detecting RdRP gene that is specific to SARS-CoV-2
➢ Each assay contains an internal control (IC) to exclude the possibility
of false-negative results due to inefficient or false RNA extraction.