COVID-19-N-Antigen Schnelltest SARS-CoV-2
Manufactured by Aripa Biotec GmbH, Germany - https://aripa-biotec.com/
Device identification number
2169
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Pathogens detected
SARS-CoV
Lineages detected
A.23.1 (United Kingdom), AT.1 (Russia), B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.427 (USA), B.1.429 (USA), B.1.525 (Nigeria), B.1.526 (USA), B.1.526.1 (USA), B.1.526.2 (USA), B.1.616 (France), B.1.617.1 (India), B.1.617.2 (India), B.1.617.3 (India), B.1.621 (Colombia), C.36 (Egypt), C.37 (Peru), P.1 (Japan/Brazil), P.2 (Brazil), P.3 (The Philippines),
Commercial Status
Commercialised
Last Update
2021-06-03 12:21:58 CET
Comments
Positive coincidence rate(Ct value < 25)（Sensitivity）：99.33%(95% CI: 94.55%~99.82%) Negative coincidence rate（Specificity）：99.20%(95%CI: 96.32%~99.87%) Total coincidence rate: 99.25% (95%CI: 97.15%~99.78%)
Assay Type
Immuno-Antigen
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Capture
LOD
28.75 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1 AU
Fn
1 AU
Precision
Evaluated
Accuracy
99.25 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.33 %
Clinical Specificity
99.2 %
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