Description
|
Target region |
N gene, ORF1ab(NSP2) gene, ORF1ab(NSP3) gene |
|
Internal control gene |
Endogenous control (human RNaseP) |
|
Specimens |
Human nasopharyngeal or oropharyngeal swab |
|
Assay type |
Qualitative detection |
|
Detection technology |
Real-time polymerase chain reaction |
|
Limit of Detection (LoD) |
ABI 7500Fast: 4~7 copies/㎕, CFX96: 4~5 copies/㎕ |
|
Analytic specificity |
No amplification 32 pathogens except SARS-CoV-2 |
|
Clinical performance |
Clinical sensitivity: 100%, Clinical specificity: 100%, (n=60) |
|
Reaction volume |
20 ㎕ |
|
TAT time |
~ 1.5 h |
|
Storage |
-25℃ ~ -15℃ |
|
Shelf life |
6 months |
|
Compatible instruments |
ABI 7500 fast Real-time PCR system (Thermo Fisher Scientific) CFX96™ Real-time PCR Detection system (Bio-Rad) |
|
Certifications |
MFDS, CE-IVD |