2019-nCoV Nucleic Acid Detection Kit (RT-IMSA Method)
Manufactured by Guangdong Longsee Biomedical Co. Ltd., China - www.longseemed.com
Device identification number
1217
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
Time
40 minutes
LOD
300 AU
Positive control
100 AU
Negative control
0 AU
Analytical Sensitivity
99 %
Analytical Specificity
96 %
Clinical Sensitivity
99 %
Clinical Specificity
95 %
Throughput
86 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