FIAflex SARS-CoV-2 Antigen FIA
Manufactured by Acon Biotech (Hangzhou) Co. Ltd., China - https://www.aconbio.com/
Device identification number
1669
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV
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.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
95 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.48 % (2 out of 411 - Nasal Swab)
False positives
0 % 0 out of 156 - Nasopharyngeal Swab
False negatives
2.54 % (4 out of 157 - Nasal Swab)
False negatives
2.17 % (3 out of 138 - Nasopharyngeal Swab)
Precision
Evaluated
Accuracy
98.9 (Nasal Swab)
Accuracy
99 % (Nasopharyngeal Swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.5 % (Nasal Swab)
Clinical Sensitivity
97.8 (Nasopharyngeal Swab)
Clinical Specificity
99.5 (Nasal Swab)
Clinical Specificity
100 (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