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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



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
2022-04-20 12:09:38 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
Crossreactivity
Evaluated
Fp
9.09 % (10 out of 110)
Fn
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