Introduction
COVID-19 Coronavirus Real Time PCR Kit is an In Vitro Diagnostic (IVD) reagent applying on fluorescent PCR technology and aiming at qualitatively detect Open Reading Frame gene region (ORF1a/b) and viral nucleocapsid region (N) of SARS-CoV-2 RNA from upper and lower respiratory tract specimens.
Upper respiratory tract specimens include throat swab and nasopharyngeal swab. Lower respiratory tract specimens include sputum.
The product is intended for use on populations suspected to have SARS-CoV-2 infection, as an aid in the diagnosis of SARS-CoV-2 infection by trained laboratory personnel on RT-PCR.
Features
- Multiplex real-time PCR detect different target specific for SARS-CoV-2
- Internal control ensures the whole process reliably
- Better performance makes the result more accurate
- More efficient: 96 tests in 72 minutes (on an instrument)
- Suitable for more mainstream instrument
- Shelf life: 12 months
Parameters
| Target |
ORF1a/b, N genes and RNaseP as IC |
| Clinical Sensitivity |
100% |
| Clinical Specificity |
99.8% |
| Limit of detection |
350 copies/mL |
| Sample input volume |
5μL |
| Sample type |
Nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes, bronchoalveolar lavage (BAL) fluid and sputum specimens. |
| Catalog |
Product |
Package
|
| JC10223-1NW |
COVID-19 Coronavirus Real Time PCR Kit |
50 Tests/Kit |
Certificate
NMPA, CE, FDA-EUA, WHO-EUL, ANVISA, TGA, SAHPRA, SFDA
Download
EUA-Fact sheet for healthcare-Bioperfectus.pdf
EUA-Fact sheet for patients-Bioperfectus.pdf
EUA-Bioperfectus-IFU.pdf
