Chemtrue® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold)
Manufactured by Shanghai Chemtron Biotech Co. Ltd., China - http://www.chemtronbio.com
Device identification number
2308
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Coronaviruses (HCoV), Influenza A, Influenza B, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Product Code:8045C
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
10 minutes
Detection Principle
Colloidal gold
LOD
50 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % without false positives compared with other methods in Clincal datas
False negatives
4 % ((CoVID-19))
False negatives
2 % ((InfluA and InfluB and RSV and ADV) )
Precision
Evaluated
Accuracy
97.93 % ((RSV))
Accuracy
98.34 % ( ADV compared with other methods in Clincal datas)
Accuracy
95.85 % ((COVID-19) )
Accuracy
98.34 % ((Influ B))
Accuracy
97.51 % ((Influ A) )
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.98 % ((COVID-19))
Clinical Sensitivity
96.23 % ( (Influ A) )
Clinical Sensitivity
97.33 % ((Influ B))
Clinical Sensitivity
94.79 % ((RSV))
Clinical Sensitivity
97.12 % (ADV compared with other methods in Clincal datas)
Clinical Specificity
100 % ((COVID-19) )
Clinical Specificity
100 ((Influ A) )
Clinical Specificity
100 ((Influ B))
Clinical Specificity
100 ((RSV))
Clinical Specificity
100 (ADV compared with other methods in Clincal datas)
Type of antigen
Nucleoprotein
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