Chemtrue® COVID-19 Ag Rapid Test (Colloidal Gold)
Manufactured by Shanghai Chemtron Biotech Co., Ltd., China - http://www.chemtronbio.com/
Device identification number
2313
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-06-28 11:11:55 CET
Comments
Product Code：8040C
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
10 minutes
Detection Principle
Colloidal gold
LOD
50 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % without false positive compared with RT-PCR in clincal datas
Fn
5 % ((Nasopharyngeal swab specimens))
Fn
5 % ((oropharyngeal swab specimens)compared with R)
Precision
Evaluated
Accuracy
95.19 % ((nasopharyngeal swab specimens)，)
Accuracy
94.71 % ((oropharyngeal swab specimens）)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.96 % ((nasopharyngeal swab specimens)，)
Clinical Sensitivity
92.25 % ((oropharyngeal swab specimens）)
Clinical Specificity
100 % ((nasopharyngeal swab specimens))
Clinical Specificity
100 % (（oropharyngeal swab specimens）)
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