Artron COVID-19 IgM/IgG Antibody Test
Manufactured by Artron Laboratories Inc., Canada - http://www.artronlab.com/
Device identification number
1729
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual, Near POC / POC
Physical Support
N.A.
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
30 minutes
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.72 % IgM (combined data from 6 centers)
False positives
0.22 % IgG (combined data from 6 centers)
False negatives
14.83 % IgM (combined data from 6 centers)
False negatives
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
Analysis of cross reactivity
Evaluated
False positives
1.87 % (26 false positives out of a total of 1393 RT-PCR confirmed non-COVID-19 specimens)
False negatives
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