2019-Novel Coronavirus, Influenza Virus, Respiratory Syncytial 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
1623
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
This kit uses polymerase chain reaction (PCR) technology based on TaqMan fluorescent probe to detect ORF1ab gene of 2019-Novel Coronavirus, M1 gene or NS1 gene of Influenza Virus and F gene of RSV from specimens including Oropharyngeal swabs, sputum and bronchoalveolar lavage fluid collected from the patients or suspected patients.
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
32 minutes
LOD
100 copies/ml (2019-nCoV)
Positive control
Armored RNA of nCoV, Flu, RSV and Internal Control
Negative control
Plasmid of Internal Control
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
98.67 %
Clinical Specificity
99.32 %
Throughput
96 samples/run
Notes
LOD: influenza virus: 400 copies/ml; RSV: 200 copies/ml
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