COVID-19 Antigen Rapid Test (Vstrip)
Manufactured by AEP Alliance (Taiwan)(AnTaimmu BioMed Co., Ltd, EirGenix, Inc and Panion & BF Biotech) - https://antaimmu.com/ http://www.eirgenix.comhttps://www.pbf.com.tw/
Device identification number
1451
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasal swab
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
10 minutes
Detection Principle
Colorimetry
LOD
1.571035 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
92.31 % Positive predictive value: % (95%CI: 62.97%- 98.83%)
Fn
96.49 % Negative predictive value: 96.49% (95%CI: 88.40%-99.00%)
Precision
evaluated
Accuracy
95.71 % CI95%:: 87.98%-99.11%
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
85.71 % CI95%: 57.19%- 98.22%
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