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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 IgM

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

Device identification number
2464
CE Marking
Yes
HSC common list (RAT)
×No
Format
Fully automated (robot)
Physical Support
Cartridge
Target type
IgM
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
Ensayo inmunoquimioluminiscente (CLIA) para la determinación semicuantitativa de anticuerpos IgM para la proteína de la nucleocápside (NCP) del SARS-CoV-2 en plasma y suero humanos. El equipo está destinado para el seguimiento de pacientes infectados. Además, el equipo puede utilizarse al realizar pruebas a la población y al personal sanitario en busca de individuos "pauci" potencialmente infecciosos o asintomáticos en la fase inicial de la infección, en combinación con las pruebas moleculares del SARS-COV-2.
Assay Type
Immuno-Antibody
Method
CLIA
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
100 %
Clinical Specificity
98 %
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