Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal AmplificationReal Time Fluorescence Assay)
Manufactured by Ustar Biotechnoligies, China - http://en.bioustar.com/
Device identification number
2600
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC, Other
Physical Support
Cassette
Target
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum
Pathogens detected
Bordetella Pertussis, Herpes Simplex (HSV), Influenza A, Influenza B, Mycobacterium Tuberculosis, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2021-09-03 11:50:10 CET
Comments
This kit used Cross Priming Amplification (CPA) to detect ORF1ab and N gene sequences specific to the novel coronavirus (2019-nCoV).
Assay Type
Nucleic acid-Other
Reader Required
No
Subcategory
Other
Method
Other
Measurement
Qualitative
Time
49 minutes
Subclass
Multiple
Detection Principle
Fluorescence
LOD
200 cpm
Positive control
Pseudovirion
Negative control
Pseudovirion with GAPDH gene
Analitical Specificity
100 %
Clinical Sensitivity
98 %
Clinical Specificity
95.4 %
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