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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Spike 1&2 IgG

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

Device identification number
2456
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Physical Support
Microplate
Target type
IgG
Specimen
Plasma, Serum
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-16 05:06:07 CET
Comments
Enzyme ImmunoAssay (ELISA) for the determination of IgG antibodies to COVID-19 Spike antigens in human plasma and sera. The IgG assay is intended for testing: (a) health-care workers at risk of COVID-19 infection to verify whether or not they might be positive for potentially neutralizing anti Spike IgG; (b) normal population for epidemiology studies on presence of potential “protective” IgG to COVID-19 Spike antigens; (c) PCR-negative infected individuals, successfully recovered from infection, to assure presence of potentially neutralizing antibodies; (d) human donors, recovered from COVID-19 infection, positive for anti-Spike IgG for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (e) vaccinated individuals to assure a reliable positive immunization with development of anti Spike IgG antibodies
Assay Type
Immuno-Antibody
Method
ELISA
Measurement
Quantitative
Time
105 minutes
LOD
2 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % None
Fn
0 % None
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
98 %
Type of antigen
Spike 1&2

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