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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19-N-Antigen Schnelltest SARS-CoV-2

Manufactured by Aripa Biotec GmbH, Germany - www.aripa-biotec.com 

Device identification number
2169
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
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