SARS-CoV-2 Neutralization Antibody Test Kit (ELISA)
Manufactured by Jiangsu Mole Bioscience Co. Ltd., China - http://en.molechina.com/
Device identification number
2338
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Semi-automated
Physical Support
Microplate
Target type
Antibody
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 Neutralization Antibody Test Kit (ELISA) is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of neutralization antibodies to SARS-CoV-2 in human serum or plasma specimen (dipotassium EDTA, lithium heparin and sodium citrate).
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
ELISA
Measurement
Qualitative
Time
120 minutes
Subclass
Enzyme-linked
LOD
5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.47 %
False negatives
2.39 %
Precision
Evaluated
Accuracy
98.39 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.53 %
Clinical Specificity
97.61 %
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