Chemtrue® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold)
Manufactured by Shanghai Chemtron Biotech Co. Ltd., China - http://www.chemtronbio.com/
Device identification number
2307
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)
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：8043C
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
10 minutes
Detection Principle
Colloidal gold
LOD
50
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 % ((RSV) compared with other methods in Clincal datas)
False negatives
2 % ((Influ A and B) )
Precision
Evaluated
Accuracy
95.85 % ((COVID-19))
Accuracy
98.34 % ((RSV) compared with other methods in Clincal datas)
Accuracy
98.34 % ((Influenza B))
Accuracy
97.51 % ((Influenza A))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.98 % ((COVID-19))
Clinical Sensitivity
96.23 % ((Influenza A) )
Clinical Sensitivity
97.33 % ((Influenza B))
Clinical Sensitivity
95.83 ((RSV) compared with other methods in Clincal datas)
Clinical Specificity
100 ((Influenza B) )
Clinical Specificity
100 ((RSV) compared with other methods in Clincal datas)
Clinical Specificity
100 ((Influenza A) )
Clinical Specificity
100 % ((COVID-19) )
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