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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)

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

Device identification number
1865
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Saliva
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-12-13 10:48:20 CET
Comments
No
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
160 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.45 % (2 out of 435 - Nasal Swab)
Fp
0.28 % (1 out of 356 - Saliva)
Fn
2.94 % (5 out of 170 - Nasal Swab)
Fn
8.46 % (11 out of 130 - Saliva)
Precision
Evaluated
Accuracy
98.8 % (Nasal Swab)
Accuracy
97.5 % (Saliva)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.1 % (Nasal Swab)
Clinical Sensitivity
91.5 % (Saliva)
Clinical Specificity
99.5 % (Nasal Swab)
Clinical Specificity
99.7 % (Saliva)
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