Artron COVID-19 IgM/IgG Antibody Test
Manufactured by Artron Laboratories Inc. - http://www.artronlab.com/
Device identification number
1729
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual, Near POC / POC
Physical Support
N.A.
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
03/25/2021 05:53
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
30 minutes
LOD
0 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
1.72 % IgM combined data from 6 centers
Fp
0.22 % IgG combined data from 6 centers
Fn
14.83 % IgM combined data from 6 centers
Fn
6.01 % IgG combined data from 6 centers
Precision
evaluated
Accuracy
93.64 % IgM combined data from 6 centers
Accuracy
94.2 % IgG combined data from 6 centers
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
85.17 % IgM combined data from 6 centers
Clinical Sensitivity
83.99 % IgG combined data from 6 centers
Notes
Manual or automated lateral flow
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0
Calibration
not evaluated
Crossreactivity
evaluated
Fp
1.87 % 26 false positives out of a total of 1393 RT-PCR confirmed non-COVID-19 specimens
Fn
7.7 % 59 false negatives out of a total of 762 RT-PCR confirmed COVID-19 specimens
Precision
evaluated
Accuracy
96.06 (IgG+IgM)
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
97.49 (IgG+IgM) 14 days post infection
Notes
rapid diagnostic test lateral flow
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