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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 (RAT)
Yes
Format
Automated, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), 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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 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