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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

RapidFor SARS-CoV-2 Rapid Ag Test

Manufactured by Vitrosens Biotechnology Co., Ltd, Turkey - www.vitrosens.com 

Device identification number
1443
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Lab-based, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
Commercial Status
Commercialised
Last Update
2021-10-21 12:03:35 CET
Comments
1.This product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021. 2.This product was evaluated and approved by Ministry of Health Turkey in Dec 2020. 3.The LOD for this product was 100 TCID50/mL.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colorimetry
LOD
100 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.95 % (5 out of 525 (Nasopharyngeal Swab))
Fn
2.7 % (17 out of 630 (Nasopharyngeal Swab))
Precision
Evaluated
Accuracy
98.09 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.3 %
Clinical Specificity
99.05 %
Type of antigen
Nucleocapsid protein

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