2019-nCoV TaqMan RT-PCR Kit Dx (DxTM67100)
Manufactured by Norgen Biotek Corp., Canada - norgenbiotek.com/
Device identification number
1158
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://norgenbiotek.com/product/2019-ncov-taqman-rt-pcr-kit-dx
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
45 minutes
LOD
10 virus-copies
Positive control
contains the CDC 2019-nCoV markers (N1 and N2) and RNase P gene
Negative control
Nuclease-free water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Throughput
96 samples/run
Notes
Information provided by the manufacturer: 2019-nCoV TaqMan RT-PCR Kit Dx provides SARS-CoV-2 detection based on the assays and protocols developed by the CDC. The kit utilizes RT-PCR for the amplification of specific target sequences and target specific probes for the detection of the amplified cDNA. The Primer & Probe Mixes contain all 3 CDC developed assays in individual tubes where probes are labelled with the fluorophore FAM. All assays are premixed to the working concentrations recommended by the CDC. The Positive Control contains two nCoV nucleocapsid target gene RNA (N1 and N2) and RNase P (internal control). The kit contains a positive control to monitor for PCR inhibition, and to validate the quality of the sample and the detection result. The 2019-nCoV TaqMan RT-PCR Kit Dx comprises Master Mix for the target and PCR control detection, 3 target Primer & Probe Mixes, as well as a positive control and a negative control (nuclease-free water) to confirm the integrity of the kit reagents.
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements