cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit
Manufactured by GenScript Biotech Corporation, China - https://www.genscript.com/
Device identification number
2860
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Microplate
Target type
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit is authorized with FDA EUA authorization. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance.
Assay Type
Immuno-Antibody
Method
ELISA
Measurement
Quantitative
Time
90 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % Compared to PRNT50 and PRNT90, out of 88 negative samples, 0 is positive
False negatives
0 % Compared to PRNT50 and PRNT90, out of 26 positive samples, 0 is negative
Precision
Evaluated
Accuracy
100 % (Neutralizing antibody)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % (Neutralizing antibody)
Clinical Specificity
100 % (Neutralizing antibody)
Type of antigen
Spike protein
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