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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Salocor SARS-CoV-2 Antigen Rapid Test Kit

Manufactured by Salofa Oy, Finland - https://www.salofa.com 

Device identification number
2240
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The SARS-CoV-2 Antigen Rapid Test Kit is a rapid chromatographic immunoassay for the for qualitative detection of SARS-CoV-2 nucleocapsid protein in human serum and nasopharyngeal swab and/or oropharyngeal swab samples. It is intended to aid in the rapid diagnosis of COVID-19 infections. This rapid kit uses a fluorescence immunochromatography method to detect SARS-CoV-2 N antigen.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
40 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.4 % ( 249/250 (Nasopharyngeal swab negative specimens) )
Fp
1 % ((186/188 serum negative specimens))
Fn
2.88 % ((135/139 Nasopharyngeal swab positive specimens) )
Fn
3.9 % ((97/101 serum positive specimens))
Precision
Evaluated
Accuracy
99.5 % ((Nasopharyngeal swab) )
Accuracy
97.9 % ((serum))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.04 % ( (serum))
Clinical Sensitivity
97.12 % ( (Nasopharyngeal swab) )
Clinical Specificity
98.9 % ( (serum))
Clinical Specificity
99.6 % ( (Nasopharyngeal swab) )
Type of antigen
Nucleoprotein

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