UltraGene® Assay SARS-CoV-2 Universalis

▪ 50 or 1000 tests per kit

▪ Multiplex format in 1 well per sample

▪ Master Mix 2X, RT Mix, Enzyme Mix and Magnesium Sulfate
▪ Specific Primers & Probes for each targeted gene: N, ORF1ab (RdRp)
▪ Positive control
▪ Negative control
▪ Internal control
▪ PCR grade nuclease-free water

Upper respiratory specimens (nasal, mid-turbinate, nasopharyngeal, oropharyngeal swab
specimens and nasopharyngeal wash/aspirate or nasal aspirate and bronchoalveolar lavage
(BAL) fluid specimens) from individuals suspected of COVID-19 by their healthcare provider

▪ Magnetic beads
▪ Validated for use with:
       ✓ Seegene STARlet instrument (Cat. #67930-03) with Hamilton Run Control software (version
           4.5.0.7977)
        ✓ Seegene STARMag 96 X 4 Universal Cartridge Kit (Cat. #744300.4.UC384)
        ✓ Any laboratory validated instrument for RNA extraction and purification using magnetic-bead
             technology shall work

▪ Any qPCR instrument compatible with the FAM, HEX, ROX and Cy5 channels.
▪ Validated for use with:
   ✓ C1000 Dx Thermal Cycler (Bio-Rad, Catalog # 1841000-IVD with CFX96-Dx ORM software version
        3.1) (C1000 CFX96),
   ✓ QuantStudio 5 Real-Time PCR Instrument (96-Well 0.1mL Block) (Applied Biosystems, Catalog
       #A28133, Design & Analysis Software 1.5.2 / Firmware Version 1.4.0)

▪ Less than 20 minutes for up to 48 samples
▪ Less than 40 minutes for up to 96 samples

▪ 1.15 TCID50/mL for SARS-CoV-2 with the C1000 CFX96 Dx Thermal Cycler and the QuantStudio 5 Real-Time PCR        Instruments

▪ The positive (PPA) and negative (NPA) percent agreements between the UltraGene Assay
SARS-CoV-2
▪ Universalis V2.X and CE-IVD EUA test are for the C1000 CFX96:
▪  PPA = 28/28 = 100% (95% C.I. = 84.98% – 100%)
▪  NPA = 30/30 = 100% (95% C.I. = 85.86% – 100%)

Clinical Accuracy at 96%