Boditech Quick™ COVID-19 Neutralizing Ab
Manufactured by Boditech Med Inc., South Korea - https://www.boditech.co.kr/en
Device identification number
2785
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), Herpes Simplex (HSV), Influenza A, Influenza B, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Boditech Quick™ COVID-19 Neutralizing Ab is a chromatographic Immunoassay for the qualitative detection 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
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Membrane-based
LOD
PRNT50 1:27
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.1 % (1 false positive out of 90 PRNT negative samples)
False negatives
6.5 % (5 false negative out of 77 PRNT positive samples)
Precision
Evaluated
Accuracy
96.4 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.5 % (95% C.I. 85.68~97.19%)
Clinical Specificity
98.9 % (95% C.I. 93.97~99.80%)
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