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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CLINITEST Rapid Covid-19 Antigen Test

Manufactured by Siemens Healthineers, Germany - www.siemens-healthineers.com 

Device identification number
1218
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-10-13 05:44:23 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Fp
0.23 % (2 out of 865)
Fn
0 % 0
Accuracy
99.42 % (Nasopharyngeal swab)
Accuracy
98.73 % (Nasal swab)
Clinical Sensitivity
98.32 % (Nasopharyngeal Swab)
Clinical Sensitivity
97.25 % (Nasal swab)
Clinical Specificity
99.6 % (Nasopharyngeal Swab)
Clinical Specificity
100 % (Nasal swab)
Type of antigen
S1, S1-RBD, S2, N proteins

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