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
2145
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card, Cassette, Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Human Metapneumovirus (HMPV), MERS-CoV, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4
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
This kit is intended to be used for in-vitro qualitative detection of SARS-CoV-2 antigens in human naso-/oropharyngeal swab and saliva samples. 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
10 minutes
Subclass
Sandwich, Double
LOD
25.55 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.31 %
False negatives
2.35 %
Precision
Evaluated
Accuracy
97.66 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.69 %
Clinical Specificity
97.65 %
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