COVID-19/FluA/FluB Antigen Detection Kit (Colloidal Gold)
Manufactured by Zhuhai Lituo Biotechnology Co. Ltd., China - www.lituo.com.cn
Device identification number
5792
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza B, MERS-CoV, SARS-CoV
Pathogens detected
Influenza A, Influenza B, SARS-CoV
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3
Commercial Status
Commercialised
Last Update
2022-12-02 10:42:50 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
570 TCID50/ml
Calibration
Evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
%
False negatives
1.4 %
Precision
Evaluated
Accuracy
99.55 %
Robustness
Evaluated
Clinical Sensitivity
99 %
Clinical Specificity
99.71 %
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