CoV-Check DIRECT Covid-19 Antigen Test
Manufactured by Spark Diagnostics LLC - https://www.sparkdiagnostics.com
Device identification number
1196
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
03/24/2021 04:16
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
380 AU
Fp
0.9 %
Fn
8.6 %
Accuracy
95.7 %
Clinical Sensitivity
93.1 %
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