COVID-19 Neutralizing Antibody Multiple Detection Kit
Manufactured by Zhejiang Hongyu Medical Commodity Co. Ltd., China - http://www.cnhongyu.cn/
Device identification number
2310
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Target type
Antibody, IgG
Specimen
Peripheral blood, Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
the LOD value of Neutralizing Antibody of the COVID-19 Neutralizing Antibody multiple Detection Kit is 1:512. The LOD value of IgG of the COVID-19 Neutralizing Antibody multiple Detection Kit is 1:512.
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
512 (IgG)
LOD
512 AU (N Ab)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
8.4 % IgG (First vaccinated in 14 days)
False positives
3.4 % ((N Ab) - Completely vaccinated more than 28 days )
False positives
1.6 % IgG (Completely vaccinated more than 28 days )
False negatives
0 % IgG First vaccinated in 14 days
False negatives
0 % (N Ab) - Completely vaccinated more than 28 days
False negatives
0 % IgG Completely vaccinated more than 28 days
Precision
Evaluated
Accuracy
100 % IgG (Completely vaccinated more than 28 days)
Accuracy
% (N Ab) - Completely vaccinated more than 28 days
Accuracy
100 % IgG (First vaccinated in 14 days)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.6 (First vaccinated in 14 days: )
Clinical Sensitivity
98.6 % IgG (Completely vaccinated more than 28 days)
Clinical Sensitivity
96.6 % ((N Ab) - Completely vaccinated more than 28 days)
Clinical Specificity
100 % ((NP swab))
Clinical Specificity
100 % IgG ((OP swab))
Clinical Specificity
100 % ((Stool))
Clinical Specificity
100 % ((Sputum/oropharyngeal saliva))
Clinical Specificity
100 % ((Front Nostril))
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