INFO SARS-CoV-2 IgM/IgG Ab Test
Manufactured by Türklab Tibbi Mal. San. ve Tic. A.S., Turkey
Device identification number
1753
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 IgM/IgG Antibody Test is a rapid immunochromatographic assay for qualitatively detection IgG and IgM antibodies of coronavirus disease in human serum, plasma or whole blood.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
0 U/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
96.17 % IgG
Accuracy
93.33 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.88 % IgG
Clinical Sensitivity
87.54 % IgM
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