2019-nCoV Saliva Ag EASY TEST
Manufactured by Guangzhou Decheng Biotechnology Co. Ltd., China - www.dochekbio.com
Device identification number
2498
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Specimen
Nasal swab, Saliva
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Rhinovirus
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19. and very easy to use.
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
10 minutes
LOD
100 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.85 %
False negatives
6.09 %
Precision
Evaluated
Accuracy
96.55 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.91 %
Clinical Specificity
99.15 %
Type of antigen
Nucleocapsid protein
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