SoluM COVID-19 Ag Saliva
Manufactured by Philosys, South Korea - www.philosys.com
Device identification number
2829
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cartridge
Target type
Antigen
Targets
spike protein
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.529 (Omicron)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Various variants of SARS-CoV-2 virus are emerged majorly due to the mutation of Spike protein(S) • Therefore, accuracy of PCR test, vaccine are affected as they aim at Spike protein • On the other hand, accuracy of Gmate COVID-19 Ag test kit is not affected as it aims at Nucleocapsid (N) for its test
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
5.07 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
9.09 % (10 out of 110)
False negatives
9.09 % (100 out of 110)
Precision
Evaluated
Accuracy
96.67 %
Accuracy
98.87%
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.84 %
Clinical Specificity
schwalbach
Type of antigen
Nucleocapsid protein
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