SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Real Time RT-PCR )
Manufactured by TransGen Biotech Co., Ltd., China - www.transgenbiotech.com/
Device identification number
1750
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
60 minutes
LOD
0.5 copies/μl
Positive control
In vitro transcribed RNA for ORF1ab, N genes and the internal control-RP gene
Negative control
RNase-free Water
Analytical Sensitivity
100 %
Analitical Specificity
100 %
Clinical Specificity
97 %
Clinical Specificity
98 %
Throughput
96 samples/run
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