COVID-19 Antigen Test Kit (Colloidal Gold)
Manufactured by Shenzhen Yilifang Biotech Co. Ltd., China - http://www.yilifangbio.com/en/
Device identification number
2333
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Rhinovirus A, Rhinovirus B, SARS-CoV, Varicella Zoster Virus (VZV)
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Please check the official website for details. http://www.yilifangbio.com/en/
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
35 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
7.18 % ((12 false positives in 167 sample))
False negatives
1.5 % ((5 false negatives in 333 sample))
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.88 %
Clinical Specificity
96.47 %
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