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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 - proelbiotech.com/ 

Device identification number
1482
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody, IgG
Specimen
Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
110 minutes
LOD
1 AU (1)
Calibration
not evaluated
Crossreactivity
evaluated
Fp
0 % (0 as determined by testing 88 samples collected prior February 2019)
Fn
0 % (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
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