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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

MediPort Limited

Manufactured by Beijing Beier Bioengineering Co., Ltd, China - www.beierbio.com/ 

Device identification number
1969
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Card
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab, Other
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
Type of antigens S1, S1-RBD, S2, N proteins
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
130 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 AU
Fn
0 AU
Precision
Not evaluated
Accuracy
98.5 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.5 % ((95% CI: 93.7%~99.3%))
Clinical Specificity
99.8 %
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