Coronavirus (2019-nCoV) -Antigentest
Manufactured by Beijing Hotgen Biotech Co. Ltd., China - www.hotgen.com.cn
Device identification number
2292
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
A.23.1, AT.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.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product was evaluated by PEI with Ja（AT055/20）in Germany; Approval by BfArM GZ: 5640-S-057/21
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
250
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
97.31 % (（Antigen）)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.37 % (（Antigen）)
Clinical Specificity
99.13 % (（Antigen）)
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