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 (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum
Cross-reactivity (pathogens tested)
Bordetella Pertussis, Herpes Simplex (HSV), Influenza A, Influenza B, Mycobacterium Tuberculosis, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
JRC-S
Detection Principle
Fluorescence
LOD
200 cpm
Positive control
Pseudovirion
Negative control
Pseudovirion with GAPDH gene
Analytical 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