SARS-CoV-2 Antigen Rapid Qualitative Test
Manufactured by Xiamen Biotime Biotechnology Co. Ltd., China - www.biotime.cn/En_
Device identification number
5746
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cartridge
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Beta Coronavirus OC43 (HCoV-OC43), MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.7 (Alpha), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.3, C.37 (Lambda)
Commercial Status
Commercialised
Last Update
2022-11-03 08:43:19 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
1600 TCID50/ml
Calibration
Evaluated
Analytical Sensitivity
95 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
samples
False negatives
samples
Precision
Evaluated
Accuracy
97.72 %
Robustness
Evaluated
Clinical Sensitivity
88.18 %
Clinical Specificity
99.99 %
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