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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 NCP IgG

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

Device identification number
2463
CE Marking
Yes
HSC common list (RAT)
×No
Format
Fully automated (robot)
Physical Support
Cartridge
Target type
Antibody, 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 semi-quantitative determination of IgG antibodies to SARS-CoV-2 Nucleocapsid protein (NCP) in human plasma and sera. The kit is intended for monitoring of infected patients. In addition the kit may be used when testing the population and health-care workers looking for potentially infective “pauci” or a-symptomatic individuals in the early phase of infection, in combination with SARS-COV-2 molecular tests. The device has been adapted for the use in exclusive combination with the Dia.Pro CLIA random access instrument named SARA
Assay Type
Immuno-Antibody
Method
CLIA
Measurement
Quantitative
Time
35 minutes
Detection Principle
Chemiluminescence
LOD
2 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % Common autoantibodies in Autoimmune Diseases did not generate false positive results
False negatives
0 % No false negative result was found
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Specificity
99 %
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