COVID-19 Antigen Test Cassette (For Analyzer)
Manufactured by Acro Biotech Inc., United States - www.acrobiotech.com
Device identification number
1700
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
6.7 AU
False negatives
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