Rapid Response COVID-19 IgG/IgM Rapid Test Device
Manufactured by BTNX Inc., Canada - www.btnx.com/
Device identification number
2033
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Rapid Response COVID-19 IgG/IgM Rapid Test Device has been CE marked since April of 2020. Since then various independent evaluations have been completed at various EU member state organizations. The "COVID-19 In Vitro Diagnostic Medical Devices" mentions that the product is not CE marked. The name of the product has been slightly changed since the first CE marking which could be the cause of this being missed. Could you please check and update the list during the next meeting of JRC? Thank you, Khasim Technical Operations Manager khasim@btnnx.com
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
210
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 % IgM
False positives
3 % IgG
False negatives
5 % IgM
False negatives
1 % IgG
Precision
Evaluated
Accuracy
97.7 % IgM
Accuracy
98.7 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.7 % IgM
Clinical Sensitivity
98.8 % IgG
Clinical Specificity
99.1 % IgM
Clinical Specificity
98.7 % IgG
Type of antigen
Other
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