SARS-COV-2 Antigen Rapid Test Kit
Manufactured by Jiangsu Baozhilin Medical Co Ltd, China
Device identification number
5754
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Herpes Simplex (HSV), Influenza A H3N2, Influenza B
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-11-07 02:09:56 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
1000 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
samples
False negatives
2 samples
Precision
Not evaluated
Accuracy
99.61 %
Robustness
Not evaluated
Clinical Sensitivity
98.2 %
Clinical Specificity
100 %
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