CLINITEST® Rapid COVID-19 Antigen Test
Manufactured by Healgen Scientific, United States - https://www.healgen.com/
Device identification number
2737
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
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Rationale: Updating already-existing listing to correct the manufacturer and antigen type
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
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
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