High Accuracy Run time 50 min Easy to Use MFDS approved CE-IVD Marked > Intended Use • In vitro diagnostic medical devices: IVDs • Respiratory specimens such as oropharyngeal or nasopharyngeal swabs 1 Features & Advantages • One-step RT-PCR in a single-tube • Since the human RNase P gene is used as an internal control, it is possible to check whether the test result is accurate or not by monitoring the entire test process such as sample collection, RNA extraction, and RT-PCR • High sensitivity and high specificity - Limit of detection (LoD) : 1 copy/gl (5 copies/reaction) • User-friendly and simple procedure • Accurate diagnosis regardless of the SARS-CoV-2 Variants (Alpha, Beta, Gamma, Delta, Omicron) • Result report is served to Lab by providing Report system (Viewer program)

■ Product principle • Real-time RT-PCR • Targeted genes : RdRp gene and N gene •The Kit includes the primers and probe set targeting the human RNase P gene that serves as an internal positive control for the validation of whole procedures, including specimen collection, RNA purification, and PCR * All clinical samples should be tested for human RNase P gene to control for specimen quality and extraction. (source: CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel_ Effective: 01 Dec 2020) ■ Analysis of Results Ct. value for controls Controls Cut-off Targets Note: Cautions...

SARS-CoV-2 Variant Virus Detection Test■ SARS-CoV-2 Variant Virus Classification and Definition Name (WHO Label) • Used Kit : PaxView® SARS-CoV-2 real-time RT-PCR Kit • Used Equipment : CFX96 (Bio-Rad) • Used Specimen : SARS-CoV-2, SARS-CoV-2 variants (Alpha, Beta, Gamma, Delta) • Specimen Source : NCCP (National Culture Collection for Pathogens) of Korea Disease Control and Prevention Agency • Test Method : Test with 1/10 serial dilution of each virus Case SARS-CoV-2 Alpha Beta Gamma Delta • The test results indicated that PaxView® SARS-CoV-2 real-time RT-PCR Kit detected SARS-CoV-2 and SARS-CoV-2...

Comparison of analytical sensitivity • Kit : PaxView® SARS-CoV-2 real-time RT-PCR Kit and 4 Kits approved by the MFDS(KFDA) • Real-time PCR instrument : CFX96 (Bio-Rad) • Sample : Positive reference materials(Vircell), SARS-CoV-2 influx from china (19B), SARS-CoV-2 UK variant (Alpha), SARS-CoV-2 South Africa variant (Beta) ► Comparison with Positive reference material Case ► Comparison with SARS-CoV-2 Variants • As a result of comparative analysis in positive reference materials, PaxView® SARS-CoV-2 real-time RT-PCR Kit detected positive reference material at a lower concentration than the comparison...