SARS-CoV-2 One-Step RT-PCR Kit
Manufactured by NZYTech, Portugal - www.nzytech.com
Device identification number
1927
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
Assay validated on widely used qPCR instruments including ABI® 7500, ABI® StepOnePlus™, ABI® QuantStudio™ 6, Bio-Rad® CFX96, Qiagen® Rotor-Gene Q, Roche® LC 480 II. NZYTech SARS-CoV-2 One-Step RT-PCR Kit, RdRp and N genes (IVD) provides the complete set of reagents and probes to qualitatively detect the SARS-CoV-2 genome, through common realtime PCR platforms. The virus RNA dependent RNA polymerase (RdRp) and the Nucleocapsid phosphoprotein (N) genes have previously been identified as highly specific markers for SARS-CoV-2. This NZYTech kit targets specific regions in the RdRp and N genes of SARS-CoV-2 genome to provide the highest sensitivity of detection.
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
0.15 cpu
Positive control
SARS-CoV-2(RdRp & N genes)/RP Positive Control
Negative control
SARS-CoV-2 Neg (RdRp & N) - RNase/DNase free water
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Notes
target RdRp and N Genes
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