Expected use
- In vitro diagnostic medical devices: IVD
- Diagnosis of SARS-CoV-2 infection
- Respiratory samples such as oropharyngeal or nasopharyngeal swabs
Features and Benefits
- 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 correct, accurate or not by monitoring the whole testing process such as sample collection, RNA extraction and RT-PCR
- High sensitivity and high specificity – Limit of detection (LoD): 1 copy/µl (5 copies/reaction)
- Simple and easy-to-use procedure
- Accurate diagnosis regardless of SARS-CoV-2 variants (Alpha, Beta, Gamma, Delta, Omicron)
- The result report is sent to the laboratory by providing the reporting system (viewer program)
Product Principle
- real-time RT-PCR
- Target genes: RdRp gene and N gene
- Kit includes human targeted primer and probe set RNase P gene that serves as an internal positive control for the validation of complete procedures, including sample collection, RNA purification and PCR
Presentation Features
1. Analytical Sensitivity (Detection limit)
- Limit of detection (LoD) : 1 copy/µl (5 copies/reaction)
2. Precision
- Repeatability within CV 3%
- Reproducibility within CV 2%
3. Transfer Prevention pollution
- Prevention of transfer contamination by use of UDG
4. Analytical Specificity (cross-reactivity)
- No cross-reactivity with 26 tested respiratory pathogens
5. Analytical Specificity (interference)
- No interference with 9 tested interfering substances
SARS-CoV-2 virus variant detection test
- Kit used: PaxView® SARS-CoV-2 real-time RT-PCR kit
- Equipment Used: CFX96 (Bio-Rad)
- The specimen used: SARS-CoV-2, SARS-CoV-2 variants (alpha, beta, gamma, delta)
- Specimen source: NCCP (National Culture Collection of Pathogens) of Korea Disease Control and Prevention Agency
- Test method: test with a 1/10 serial dilution of each virus