Toyo SARS-CoV-2 IgM/IgG Ab Test
Manufactured by Türklab Tibbi Mal. San. ve Tic. A.S., Turkey
Device identification number
1723
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
Precision
Not evaluated
Accuracy
96.17 % IgG
Accuracy
93.33 % IgM
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
92.88 % IgG
Clinical Sensitivity
87.54 % 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