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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



RAMP COVID-19 Antigen Test

Manufactured by Response Biomedical Corp., Canada - www.responsebio.com 

Device identification number
2095
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cartridge, Lateral flow, Latex
Target type
Antigen
Specimen
Nasal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), P.1 (Gamma),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
LOD = 100 pfu/mL
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Other
LOD
100 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
TBD 2.5% in a study against SOFIA with subjects suspected of COVID-19.
Fn
TBD 11% in a study against SOFIA with subjects suspected of COVID-19.
Precision
Evaluated
Accuracy
95.6 % (TBD 95.6% in a study against SOFIA with subjects suspected of COVID-19.)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
89 % (TBD 89% in a study against SOFIA with subjects suspected of COVID-19.)
Clinical Specificity
97.5 % (TBD 97.5% in a study against SOFIA with subjects suspected of 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