COVID-19 Antibody Detection Kit
Manufactured by New Gene (Hangzhou) Bioengineering Co. Ltd., China - www.new-gene.net/
Device identification number
2306
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antibody, IgG, IgM
Specimen
ACD plasma, Peripheral blood, Plasma, Serum
Cross-reactivity (pathogens tested)
Adenovirus, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Mumps Virus (MuV), Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product is intended for the qualitative detection of COVID-19 antibodies (IgM and IgG). It provides an aid in the diagnosis of infection with novel coronavirus.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Sample collection device
Method
Immunoassay
Measurement
Quantitative
Time
20 minutes
Subclass
Sandwich
LOD
1
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.95 % IgM (1 out of 105)
False positives
0.95 % (1 out of 105)
False negatives
2.04 % (2 out of 98 )
False negatives
5.1 % IgM (5 out of 98)
Precision
Evaluated
Accuracy
97 % IgM
Accuracy
98.5 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.9 % IgG
Clinical Sensitivity
94.9 % IgM
Clinical Specificity
99 % IgG
Clinical Specificity
99 % IgM
Type of antigen
Other
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