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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgG/IgM Confirmation and Typing

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

Device identification number
2461
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Microplate
Target type
IgG, 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
Module-based Enzyme-Immuno-Assay (ELISA) for the confirmation of samples positive for IgG and IgM antibodies to COVID-19 in first screening. The test is particularly useful in monitoring patients, infected by COVID-19, from the time of symptoms offset up to full recovery. The test can be used in addition to identify (a) the specificity (“typing”) of antibodies to the major immunodominant COVID-19 antigens and (b) identify those samples with a titer of “potentially” neutralizing IgG to Spike antigens such to select the donor as a candidate for immunotherapy, as well.
Assay Type
Immuno-Antibody
Method
ELISA
Measurement
Qualitative
Time
105 minutes
LOD
2 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % No false positive reactions were observed
False negatives
0 % No false negative result was found
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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