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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 (RAT)
Yes
Format
Lab-based, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
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.2.75, BA.2.12.1,BA.2.12,BA.5,), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-10-20 10:15:02 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
Other (chromatographic immunoassay)
LOD
160 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.56 % (1 out of 176 (Nasopharyngeal Swab))
False positives
0.45 % (2 out of 435 (Nasal Swab))
False negatives
2.94 % (5 out of 170 (Nasal Swab))
False negatives
2.43 % (3 out of 123 (Nasopharyngeal Swab))
Precision
Evaluated
Accuracy
98.8 % (Nasal Swab)
Accuracy
98.7 % (Nasopharyngeal 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