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.
|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|
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
Research Use Only in the United States.
CE Marked IVD for EU Market.