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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

NanoRepro SARS-CoV-2 Antigen Rapid Test

Manufactured by NanoRepro AG, Germany - https://www.nanorepro.com/ 

Device identification number
2200
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Dear Sir/Madam, We, NanoRepro AG, are manufacturer of SARS-CoV-2 Antigen Rapid Test in Germany and would like to request you to add our product in your European Commision Common List of Rapid Antigen Tests. Our NanoRepro SARS-CoV-2 Antigen Rapid Test carries CE marking, have sensitivity ≥ 90% and specificity ≥ 97% and has been successfully validated in Germany according to the criteria of Paul Ehrlich Institute (PEI) by Biomex GmbH . This validation ,which was performed by Biomex GmbH , Heidelberg, has been accepted by Bundesinstitute für Arzneimittel und Medizinprodukte and Paul Ehrlich Institute. We look forward to receiving a positive response. Best Regards Ramila Sedai Regulatory Affairs Manager NanoRepro AG
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
30 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.63 % (Among 550 specimens, 9 test results were false positives.)
False negatives
2.8 % (Among 250 specimens, 7 test results were false regatives.)
Precision
Evaluated
Accuracy
98 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.2 % ( (Antigen))
Clinical Specificity
98.4 % ( (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