Gmate COVID-19 Neutralizing antibody
Manufactured by Philosys, South Korea - http://www.philosys.com/
Device identification number
2861
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
See more information via http://www.philosys.com/
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
10 AU/mL (neutralizing antibody)
LOD
2.7 ng/mL (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