SoluM COVID-19 Ag Neutralizing Antibody
Manufactured by Philosys, South Korea - http://www.philosys.com/
Device identification number
2916
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.529 (Omicron)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The kit is used to detect the total antibody and neutralizing antibody to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood sample qualitatively. It is mainly used to identify individuals with acquired immune response to the SARS-CoV-2, and to evaluate the effectiveness of the vaccine clinical trials and mass vaccination.
Assay Type
Immuno-Antibody
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
98.31 % (Neutralizing antibody)
LOD
98.31 % (Total Antibody)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.38 % (Total Antibody)
False positives
4.76 % (Neutralizing Antibody)
False negatives
1.47 % (Total antibody)
False negatives
0.74 % (Neutralizing antibody)
Precision
Evaluated
Accuracy
98.31 (Total antibody)
Accuracy
98.31 % (Neutralizing antibody)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.62 (Total antibody)
Clinical Sensitivity
95.24 % (Neutralizing antibody)
Clinical Specificity
98.53 (Total antibody)
Clinical Specificity
99.26 % (Neutralizing antibody)
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