COVID-19 Virus Antigen Detection Kit（Fluorescence Immunochromatography Assay）
Manufactured by Anhui Hua Pei Biotechnology Co. Ltd., China
Device identification number
2375
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Bronchoalveolar lavage fluid, Nasopharyngeal swab, Oropharyngeal swab, Serum
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
1,the antibodies used in the test kit can recognize COVID-19 virus Nucleocapsid protein(Wide type). 2, The false positive will occur if some saliva present in the sample, the tester should be trained to know how to take swab sample and avoid saliva contamination is recommended.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Semiquantitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Fluorescence
LOD
0.016 ng/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.4 %
False negatives
2.2 %
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.01 %
Clinical Specificity
97.9 %
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