biotical SARS-CoV-2 Ag Card
Manufactured by Biotical Health S.L.U., Spain - https://biotical.es/es/
Device identification number
2013
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Card, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
1000 TCID50/ml
LOD
1 ng/mL
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
3 %
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 %
Clinical Specificity
99 %
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