StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes)
Manufactured by Nanjing Liming BioProducts Co. Ltd., China - www.limingbio.com
Device identification number
1224
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
Comments
https://www.limingbio.com/sars-cov-2-rt-pcr-product/
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
Time
100 minutes
LOD
3.9 cpu
Positive control
The Positive Control should produce Cq value ?35 in FAM/HEX/ROX channel
Negative control
NEC or No template control is free from amplification in the all channels
Analytical Sensitivity
99.6 %
Analytical Specificity
100 %
Clinical Sensitivity
99.6 %
Clinical Specificity
100 %
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