2019-nCoV Rapid Antigen Test
Manufactured by Guangzhou Decheng Biotechnology Co. Ltd., China - www.dochekbio.com
Device identification number
2468
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Adenovirus 3, Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Rhinovirus, SARS-CoV
Lineages detected
B.1.351 (Beta), B.1.525 (Eta), 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
the product is evaluated in Swedish lab. And popularly accepted by the end use because of the easy operation.
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
10 minutes
Subclass
Sandwich, Double
LOD
100 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.5 %
False negatives
3.17 %
Precision
Evaluated
Accuracy
98.47 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.83 %
Clinical Specificity
99.5 %
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