COVID-19 Antigen Test Cassette (For Analyzer)
Manufactured by ACRO BIOTECH, Inc. - www.acrobiotech.com
Device identification number
1700
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
03/16/2021 08:52
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
6.7 AU
Fn
1.6 AU
Precision
evaluated
Accuracy
96.2 (Antigen)
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
93.3 % (Antigen)
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