SARS-CoV-2 Antigen (GICA)
Manufactured by Shenzhen Lifotronic Technology Co. Ltd., China - http://en.lifotronic.com/
Device identification number
2148
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Herpes Simplex (HSV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus
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
SARS-CoV-2 Antigen (GICA) is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen of SARS-CoV-2 virus in anterior nasal swabs collected from individuals by users.
Assay Type
Immuno-Antigen
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3.62 %
False negatives
0.62 %
Precision
Evaluated
Accuracy
98.36 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.38 %
Clinical Specificity
99.38 % (（Antigen）)
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