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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 (RAT)
Yes
Format
Lab-based, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Saliva
Cross-reactivity (pathogens tested)
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), P.1 (Gamma), P.2 (Zeta), P.3 (Theta), B.1.1.529 (Omicron), C.37 (Lambda), B.1.616
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 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
97.5 % (Saliva)
Accuracy
98.8 % (Nasal Swab)
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