LionRun™️SARS-CoV-2 Antigen Rapid Test Kit (Lateral Flow Immunoassay)
Manufactured by Shanghai Liangrun Biomedicine Technology Co. Ltd., China - www.liangrunbio.com/en/index
Device identification number
1863
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
LionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay) uses microsphere immunochromatography technology which is intended for the in vitro qualitative detection of the SARS-CoV-2 virus antigen nucleocapsid (N) protein in human nasal swab, nasopharyngeal swab, oropharyngeal swab samples.
Assay Type
Immuno-Antigen
Reader Required
N.A.
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Electrochemiluminescence
LOD
AU 25
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 (1)
False negatives
8 (8)
Precision
Evaluated
Accuracy
96.89 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92 %
Clinical Specificity
99.33 %
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