Rapid SARS-Cov2 Antigen Test
Manufactured by Immunospark s.r.l., Italy - www.immunospark.com
Device identification number
1791
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No additional information
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
Detection Principle
Chemiluminescence
LOD
3.22 IU/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 AU
False negatives
0 AU
Precision
Evaluated
Accuracy
99.72 %
Robustness
Evaluated
Clinical Sensitivity
98.5 %
Clinical Specificity
100 %
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