Chemtrue® COVID-19/Influenza A+B Ag Combo Rapid Test (Colloidal Gold)
Manufactured by Shanghai Chemtron Biotech Co., Ltd, China - http://www.chemtronbio.com
Device identification number
2314
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, Oropharyngeal swab
Pathogens detected
Coronaviruses (HCoV), Influenza A, Influenza B
Commercial Status
Commercialised
Last Update
2021-06-28 11:18:25 CET
Comments
Product Code：8041C
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
10 minutes
Detection Principle
Colloidal gold
LOD
50 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % without false positives 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）compared with RT-PCR in Clincal datas)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.96 % (（nasopharyngeal swab specimens）)
Clinical Sensitivity
92.25 % (（oropharyngeal swab specimens）compared with RT-PCR in Clincal datas)
Clinical Specificity
100 % (（nasopharyngeal swab specimens）)
Clinical Specificity
100 % (（oropharyngeal swab specimens）compared with RT-PCR in Clincal datas)
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