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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

reOpenTest COVID-19 Antigen Rapid Test

Manufactured by Zhejiang Anji Saianfu Biotech Co., Ltd, China - www.reopentest.com 

Device identification number
1295
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Automated, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Pathogens detected
Coronaviruses (HCoV), SARS-CoV
Commercial Status
Commercialised
Last Update
2021-10-29 08:20:14 CET
Comments
LoD 5.75 x 10^2 TCID50/ml
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
575 TCID50/ml
Crossreactivity
Evaluated
Fp
2 %
Fn
4 AU
Precision
Evaluated
Accuracy
98.47 % (Antigen)
Reproducibility
Evaluated
Clinical Sensitivity
97.52 % (Antigen)
Clinical Specificity
99.13 % (Antigen)
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