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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit (Lateral Flow Method) (Nasal swab)

Manufactured by Shen Zhen Zi Jian Biotechnology Co. Ltd., China - http://www.szzijian.com/ 

Device identification number
3104
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Bordetella Pertussis, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://www.szzijian.com/
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
32600 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.06 AU
False negatives
0 AU
Precision
Evaluated
Accuracy
98.5 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94 % (Antigen)
Clinical Specificity
100 % (Antigen)
Type of antigen
Nucleocapsid protein

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