2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay
Manufactured by Jiangsu Mole Bioscience Co. Ltd., China - en.molechina.com/
Device identification number
1621
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
http://en.molechina.com/Home/ProductInfo/4
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
32 minutes
LOD
137 copies/ml (2019-nCoV )
Positive control
Armored RNA of nCoV, IFA, IFB and Internal Control
Negative control
No targets
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
98.28 %
Clinical Specificity
99.68 %
Throughput
96 samples/run
Notes
LOD: Influenza A H1N1(2009): 180 copies/ml; Influenza A H1N1: 80 copies/ml; Influenza A H3N2: 120 copies/ml; Influenza A H5N1: 800 copies/ml ; Influenza A H7N9: 200 copies/ml; Influenza B Victoria: 200 copies/ml; Influenza B Yamagat
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