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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SARS-CoV-2 IgG antibody detection kit (ELISA)

Manufactured by Proel Biotech Ltd, Romania - https://proelbiotech.com/ 

Device identification number
1482
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based, Manual, Semi-automated
Physical Support
Microplate, Strip
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The kit detects anti-spike 1 and anti-nucleocapsid IgG antibodies (combined), and each lot is calibrated against the first WHO international standard. Measured values can be specified in IU/ml (BAU/ml) based on a conversion spreadsheet.
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
110 minutes
Subclass
Sandwich
LOD
0.7 AU/mL (30 IU/ml)
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % as determined by testing 88 samples collected prior February 2019
Fn
0 % as determined by testing 30 samples of recovered COVID-19 patients
Precision
Evaluated
Accuracy
100 % IgG
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
100 % IgG
Clinical Specificity
100 % IgG
Notes
manual or automated

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