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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

DIA.CHEMILUX SARS-CoV-2 ACE2-RBD NEUTRALIZATION

Manufactured by DIA.PRO Diagnostic Bioprobes Srl, Italy - www.diapro.it 

Device identification number
2479
CE Marking
Yes
HSC common list (RAT)
×No
Format
Fully automated (robot)
Physical Support
Cartridge
Target type
IgG
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Chemi-Luminescence ImmunoAssay (CLIA) for the serological determination of the neutralization activity of antibodies to SARS-CoV-2, induced by natural infection and/or vaccination, able to block the interaction of Receptor Binding Domain (RBD) and ACE2 and thus the virus infection. The assay is intended for testing sera and plasma collected from: (a) PCR-negative Covid-19 individuals successfully recovered from infection, to assure presence of anti RBD neutralizing antibodies; (b) human donors, recovered from COVID-19 infection, positive for anti-RBD antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (c) vaccinated individuals to assure a reliable and efficient immunization with development of neutralizing antibodies able to block ACE2-RBD binding
Assay Type
Immuno-Antibody
Method
CLIA
Measurement
Quantitative
Time
23 minutes
Detection Principle
Chemiluminescence
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % No false positive reaction was observed
False negatives
0 % No false negative result was found
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99 %
Clinical Specificity
98 %
Type of antigen
Other (RDB)

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