COVID-19 Antigen Saliva Test (Immunochromatography)
Manufactured by Ulti Med Products GmbH, Germany - www.ultimed.org
Device identification number
1641
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
100 AU (100)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.56 % (2 from 128)
False negatives
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