Product Overview
Description
The Firegene Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit is a real-time multiplex RT-PCR test intended for the qualitative detection of SARS-CoV-2 viral RNA.
It is suitable for upper respiratory specimens, such as nasopharyngeal, oropharyngeal swab, and bronchoalveolar lavage specimens.
In a single RT-PCR reaction, it is able to detect ORF1ab and N RNA sequences, and in addition, human RNase P as an internal control.
Specifications
| Product Type | Molecular Detection |
| Applications | RT-PCR, COVID-19 and COVID-19 Variants Detection |
| Compatible Sample Types | Nasopharyngeal and oropharyngeal swab, and bronchoalveolar lavage specimens. |
| Target | ORF1ab and N RNA sequences, and human Rnase P RNA sequence. |
| Method | Real-time multiplex fluorescent RT-PCR |
| Prep Time | < 70 minutes |
| Amount of Starting Material | 100 copies/ml of SARS-CoV-2 virus |
| Supported Instruments | Roche LC480 Real-Time PCR System or Thermo Fisher 7500 Real-Time PCR System |
| Storage | 2- 30°C |
| Shelf-life | 12 months |
Results
Variability - ORF1ab & N Gene (Inter-batch Variability <5%)
ORF1ab Linearity & LoD
The Lower Limit of Detection (LoD) is defined as the lowest concentration of ORF1ab RNA that can be consistently detected (typically in >=95% of 20 swab samples tested): 3 copies/rxn or 100 copies /mL swab
N Linearity & LoD
The Lower Limit of Detection (LoD) is defined as the lowest concentration of N RNA that can be consistently detected (typically in >=95% of 20 swab samples tested): 3 copies/rxn or 100 copies/mL swab
Restrictions
Research Use Only in the United States.
CE Marked IVD for EU Market.
Components