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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Vstrip Covid-19 Antigen Rapid Test

Manufactured by Panion & BF Biotech Inc., Taiwan ROC - www.pbf.com.tw/ 

Device identification number
1379
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
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
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colloidal gold
LOD
157 U/ml
False positives
1.8 %
False negatives
8.7 %
Accuracy
96.2 %
Clinical Sensitivity
91.3 %
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