Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Nasopharyngeal/Saliva)
Manufactured by Acon Biotech (Hangzhou) Co. Ltd., China - https://www.aconbio.com/
Device identification number
4057
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV, SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), 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.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), Other (B.1.618, B.1.640.2, AY.1, AY.4.2, BA.1, BA.1.1, BA.2, BA.3，XE，BA.4，BA.5, BA.2.12.1，BA.2.12, BA.2.75), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-09-20 01:50:51 CET
Comments
N.A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
N.A.
LOD
160 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
0.46 % (for nasal swab)
False negatives
2.94 % (for nasal swab)
Precision
Evaluated
Accuracy
98.8 %
Robustness
Evaluated
Clinical Sensitivity
97.1 %
Clinical Specificity
99.5 %
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