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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Ag Respi-Strip

Manufactured by Coris BioConcept, Belgium - www.corisbio.com 

Device identification number
133
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Dipstick
Target type
Antigen
Specimen
Nasopharyngeal swab
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
New data is the positivity on OMICRON variant (real data, not bioinformatic)
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
30 minutes
Detection Principle
Colorimetry
LOD
5000 TCID50/ml
LOD
0.25 ng/mL
Calibration
Not Reported
Analysis of cross reactivity
Cross-reactivity: no cross-reactivity for bacteria and virus tested including seasonal Coronaviruses (HKU1, 229E, OC43, NL63), positive for SARS-CoV
Accuracy
97.9 %
Clinical Sensitivity
91.2 %
Clinical Specificity
99.4 %

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