SARS-CoV-2（ COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Manufactured by Shen Zhen Zi Jian Biotechnology Co. Ltd., China - http://www.szzijian.com/
Device identification number
2491
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
A.23.1, AT.1, 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
2023-05-17 05:37:00 CET
Comments
This kit is intended to be used for in-vitro qualitative detection of SARS-CoV-2 antigens in human naso-/oropharyngeal swab . This kit uses colloidal gold immuno-lateral chromatography technology. Antigen detection is used for auxiliary diagnosis or epidemiological investigation of human infection with SARS-CoV-2.The test is for professional use only
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
326000 TCID50/ml (swab)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5.35 AU
False negatives
0.7 AU
Precision
Evaluated
Accuracy
97.46
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.65 %
Clinical Specificity
99.3 %
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