COVID-19 Virus Antigen Detection Kit（Fluorescence Immunochromatography Assay）
Manufactured by Anhui Hua Pei Biotechnology Co., Ltd.
Device identification number
2375
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Anterior nasal swab, Nasopharyngeal swab, Serum
Pathogens detected
Coronaviruses (HCoV)
Lineages detected
Commercial Status
Commercialised
Last Update
2021-07-08 10:47:24 CET
Comments
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
Reader Required
Yes
Subcategory
Other
Method
Immunochromatography
Measurement
Semiquantitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Fluorescence
LOD
0.016 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
2.88 %
Fn
2.23 %
Precision
Evaluated
Accuracy
97.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.4 %
Clinical Specificity
98.9 %
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