SARS-CoV-2 Nucleic Acid RT-PCR Test Kit
Manufactured by Hangzhou Clongene Biotech Co. Ltd., China - http://en.clongene.com/
Device identification number
1364
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
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
120 minutes
LOD
500 cpm
Positive control
Recombination DNA of SARS-CoV-2
Negative control
NaCl
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
96.92 %
Clinical Specificity
99.27 %
Throughput
48 samples per run
Notes
http://en.clongene.com/uploads/20201105/e4bd4de7b5f31428c79068cf4eda2876.pdf
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