FAMEX SARS-CoV-2 RAPID ANTIBODY TEST
Manufactured by fago medikal san. tic. ltd. şti., Turkey - http://famextestkit.com/
Device identification number
2175
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Fingertip
Target
Antibody, IgG, IgM
Specimen
Whole blood, Whole blood with anti-coagulants
Pathogens detected
Coronaviruses (HCoV), SARS-CoV
Lineages detected
A.23.1 (United Kingdom), AT.1 (Russia), B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.427 (USA), B.1.429 (USA), B.1.525 (Nigeria), B.1.526 (USA), B.1.526.1 (USA), B.1.526.2 (USA), B.1.616 (France), B.1.617.1 (India), B.1.617.2 (India), B.1.617.3 (India), B.1.621 (Colombia), C.36 (Egypt), C.37 (Peru), P.1 (Japan/Brazil), P.2 (Brazil), P.3 (The Philippines),
Commercial Status
Commercialised
Last Update
2021-06-03 05:03:57 CET
Comments
sars-cov 2 antikörper rapid test
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
100 AU
Calibration
Evaluated
Analytical Sensitivity
85 % IgM
Crossreactivity
Evaluated
Fp
10 AU
Fn
8 AU
Precision
Evaluated
Accuracy
98.6 % IgG
Accuracy
92.8 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Specificity
98 % IgG
Clinical Specificity
96 % IgM
Type of antigen
Nucleoprotein
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