SARS-Cov-2 Antigen Rapid Test Cassette (Saliva)
Manufactured by Spring Healthcare Services Sp zoo - https://springhealthcare.org/
Device identification number
1901
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
03/19/2021 06:37
Comments
SARS-Cov-2 Antigen Rapid Test Cassette (Saliva) is a rapid chromatographic immunoassay for the qualitative detection of specific antigens from SARS-CoV-2 present in human saliva within the first 7 days of symptom onset. This test is for profes- sional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
125 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
3 AU
Precision
Evaluated
Accuracy
99.09 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.69 %
Clinical Specificity
99.9 %
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