COVID-19 Antigen Rapid Test
Manufactured by ACRO BIOTECH, Inc. - www.acrobiotech.com
Device identification number
1688
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasal swab, Other
Commercial Status
Commercialised
Last Update
03/18/2021 09:03
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0
Calibration
not evaluated
Crossreactivity
evaluated
Fp
1 AU
Fn
2.3 AU
Precision
evaluated
Accuracy
98.6 % (Antigen)
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
97.7 % (Antigen)
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