Clinitest Rapid Covid-19 Antigen Self Test
Manufactured by Healgen Scientific, United States - https://www.healgen.com/
Device identification number
2238
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
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
n/a
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
115
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
97.25% Sensitivity, 100% Specificity
False negatives
97.25% Sensitivity, 100% Specificity
Precision
Not evaluated
Accuracy
98.73 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.25 %
Clinical Specificity
100 %
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