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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AESKU.RAPID SARS-CoV-2

Manufactured by AESKU.DIAGNOSTICS GmbH & Co. KG, Germany - www.aesku.com 

Device identification number
2108
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasal swab, Throat swab
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-06-18 12:48:10 CET
Comments
Intended use: The AESKU.RAPID SARS-CoV-2 rapid test is an immunochromatographic sandwich method with two specific antibodies for the qualitative detection of the N-protein antigen in human nasal swab samples. The point-of- care test is designed to detect SARS-CoV-2 N-protein antigens detectable during the acute phase of infection. The test should be performed by healthcare professionals familiar with in vitro diagnostic methods and appropriate infection control procedures. Test principle: The AESKU.RAPID SARS-CoV-2 rapid test is based on immunochromatographic polymer technology combined with the sandwich principle for the qualitative detection of the nucleocapsid protein antigen in human nasal swab samples. The sample is mixed with colored polymer-labeled SARS-CoV-2 monoclonal antibody 1 in the test device's sample well and chromatographed along the nitrocellulose membrane. If SARS-CoV-2 antigens are present in the sample, they will bind to SARS-CoV-2 antibody 1, and the mixture will bind to immobilized SARS-CoV-2 antibody 2 on the nitrocellulose membrane. The resulting complex of antibody 1, antigen, and antibody 2 forms the colored test line. The test device's control line is coated with secondary antibodies, resulting in a colored result during a standard test procedure.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
50 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1.8 % (4 false positives out of 222 negative samples)
Fn
3.66 % (4 false negatives out of 109 positive samples)
Precision
Evaluated
Accuracy
% (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % ( (Antigen))
Clinical Specificity
98 % ( (Antigen))
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