CLINITEST® Rapid COVID-19 Antigen Test
Manufactured by Healgen, United States - healgen.com
Device identification number
2362
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The RAT is already registered at https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/1767 - however with another name. To be able of using the RAT in Switzerland as an aid for the COVID-Certificate i was told it needs to have the exact same name. As the RAT with ID 1767 doesn't have the same name, eventhough it's the same test, herbey the application. If it is possible to add the name to 1767 it will work for Switzerland as well, I guess. Otherwise it needs to be added. Thank you and best regards Kristian Palas
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
1.15 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
sensitivity: 98.32% specificity: 99.6%
False negatives
sensitivity: 98.32% specificity: 99.6%
Precision
Evaluated
Accuracy
98.73 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.32 %
Clinical Specificity
99.6 %
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