Coronavirus (SARS-CoV 2) Ab IgG / IgM - Nucleocapsid (N protein)
Manufactured by Tody Laboratories Int., Romania - www.todylaboratories.com/
Device identification number
1936
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Peripheral blood, Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Nucleocapsid (N) protein as target. IgG Limit of Detection (LoD): 1:40 (0.025) IgM Limit of Detection (LoD): 1:8 (0.125)
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
0.025 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3.7 % (From studies performed by manufacturer, the false positive rate is 3.7% (specificity = 96.3%))
False negatives
3.1 % (From studies performed by manufacturer, the false negative rate is 3.1% (sensitivity = 96.9%))
Precision
Evaluated
Accuracy
96.4 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.9 %
Clinical Specificity
96.3 %
Type of antigen
Nucleocapsid (N protein)
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