COVID-19 /Flu A&B /RSV Ag Rapid Test Cassette (Swab)
Manufactured by Zhejiang Orient Gene Biotech Co.,LTD, China
Device identification number
25624
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Chlamydia Pneumoniae, Coronaviruses (HCoV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae
Pathogens detected
Adenovirus 3, Adenovirus 7, Chlamydia Pneumoniae, Coronaviruses (HCoV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Information on antigen epitope targeted by the antibodies used in the design of the device
Coating 44-175aa
Labelling 74-105aa
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2023-11-22 09:19:40 CET
Comments
N/A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
115 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
88.24 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
11.76 %
False negatives
%
Precision
Evaluated
Accuracy
97.04 %
Robustness
Evaluated
Clinical Sensitivity
88.24 %
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