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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

LionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay)

Manufactured by Shanghai Liangrun Biomedicine Technology Co. Ltd., China

Device identification number
2155
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Influenza A H1N1, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus A
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
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
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.57 %
False negatives
0.51 %
Precision
Evaluated
Accuracy
97.57 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.43 %
Clinical Specificity
99.49 %
Type of antigen
Nucleoprotein

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