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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Flowflex Anti-SARS-CoV-2 S Antibody Rapid Test

Manufactured by ACON Biotech (Hangzhou) Co., Ltd., China - https://www.aconbio.com/ 

Device identification number
2951
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody
Targets
spike protein,
Specimen
Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antibody
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.96 % (2 out of 208)
Fn
1.37 % (2 out of 145)
Precision
Evaluated
Accuracy
98.87 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.65 %
Clinical Specificity
99.04 %

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