ichroma™ COVID-19 nAb
Manufactured by Boditech Med Inc., South Korea - www.boditech.co.kr/en
Device identification number
2398
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Anti-Nuclear Antibody, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
ichroma™ COVID-19 nAb is a fluorescence Immunoassay (FIA) for the qualitative determination of neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the ACE-2 cell surface receptor in human whole blood/serum/plasma. For in vitro diagnostic use only.
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
10 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 ( (1 false positive out of 99 PRNT negative samples.))
False negatives
1 ((1 false negative out of 98 PRNT positive samples.))
Precision
Evaluated
Accuracy
99 ( (Kappa = 0.97969))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
99 % ((95% CI: 94.4 ~ 100%))
Clinical Specificity
99 % ((95% CI: 94.5 ~ 100%))
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