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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Savvycheck SARS-CoV-2 Ag

Manufactured by Savyon Diagnostics Ltd., Israel - www.savyondx.com 

Device identification number
2683
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The SavvycheckTM SARS-CoV-2 Ag is an immunoassay in which SARS-CoV-2 nucleocapsid protein antigens extracted from nasal swabs of individuals suspected of COVID-19, interact during flow along the test strip with anti-SARS- CoV-2 nucleocapsid protein specific antibodies conjugated to a red latex particles used as a detector. The resulting complex flows along the strip and interacts with immobilized anti-SARS-CoV-2 nucleocapsid-specific antibodies in the detection zone(“T”), forming an observable red-colored line. The presence of a red line at the test line position indicates a positive result. The conjugated latex particles interact downstream the test line with other specific antibodies to create the control line. The presence of a green line at the control line position indicates proper function of the test.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Other
Measurement
Qualitative
Time
10 minutes
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
3 %
Fn
1 %
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.2 %
Clinical Specificity
98.8 %

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