COVID-19 Antigen Saliva Test (Immunochromatography)
Manufactured by ulti med Products (Deutschland) GmbH - https://www.ultimed.org
Device identification number
1641
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
03/24/2021 09:38
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
100 AU 100
Calibration
not evaluated
Crossreactivity
evaluated
Fp
1.56 % 2 from 128
Fn
4.35 % 5 from 115
Precision
evaluated
Accuracy
97 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
96 %
Type of antigen
nucleoprotein
Notes
rapid diagnostic test Lateral Flow
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