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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test (Vstrip)

Manufactured by AnTaimmu BioMed, Taiwan ROC - www.antaimmu.com 

Device identification number
1451
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
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