Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit
Manufactured by MedicalSystem Biotechnology Co. Ltd., China - https://en.nbmedicalsystem.com/en/
Device identification number
2050
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Other biological fluids, Peripheral blood, Plasma, Saliva, Serum, Sputum, Stool, Throat secretion, Throat swab, Tissue homogenates, Whole blood, Whole blood with anti-coagulants
Lineages detected
A.23.1, B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N.A.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Other ()
LOD
180 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
8.23 %
False negatives
2.1 %
Precision
Evaluated
Accuracy
90 % IgG
Accuracy
90 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.9 % IgG
Clinical Sensitivity
97.9 % IgM
Clinical Specificity
91.77 % IgG
Clinical Specificity
91.77 % 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