COVID-19 Saliva Ag Test
Manufactured by Core Technology Co. Ltd.
Device identification number
1915
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
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
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
22.5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.9 %
False negatives
2.4 %
Precision
Evaluated
Accuracy
98.7 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.6 %
Clinical Specificity
99.1 %
Type of antigen
Other
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