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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

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

Device identification number
1457
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
Nasal swab, Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-10-04 08:46:09 CET
Comments
N/A
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
0.56 % (1 out of 176 (Nasopharyngeal Swab))
Fn
2.94 % (5 out of 170 (Nasal Swab))
Fn
2.43 % (3 out of 123 (Nasopharyngeal Swab))
Precision
Evaluated
Accuracy
98.7 % (Nasopharyngeal Swab)
Accuracy
98.8 % (Nasal Swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.1 % (Nasal Swab)
Clinical Sensitivity
97.6 % (Nasopharyngeal Swab)
Clinical Specificity
99.5 % (Nasal Swab)
Clinical Specificity
99.4 % ( Nasopharyngeal Swab)
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