SARS-CoV-2 S IgG ELISA
Manufactured by UAB Imunodiagnostika, Lebanon - www.allergomedica.lt
Device identification number
1740
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Microplate
Target type
IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Additional information: ELISA microplate wells are coated with recombinant SARS-CoV-2 surface spike (S) glycoprotein, which has no transmembrane. During the first stage diluted patient blood samples are incubated in ELISA microplate wells with immobilised recombinant viral protein (antigen) - SARS-CoV-2 surface glycoprotein S. In case of a positive sample, virus-specific antibodies (IgG) will bind with the antigens. Bounded specific IgG Kit for in vitro diagnostic use Catalogue No. Specific antibodies Ig class Substrate Format El-2020-9499 G SARScoronavirus-2 (SARS-CoV-2 S) IgG Antigen-coated microplate wells 96 x 1 (96 wells)2 antibodies are determined using enzyme-labelled antibodies (HRP, horseradish peroxidase) against the human IgG (enzyme conjugate). Horseradish peroxidase catalyses the colour reaction. Depending on the amount of the antibodies in the samples, the solutions of different intensities are evaluated spectrophotometrically - by measuring the optical density
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Other ()
Time
180 minutes
Subclass
Enzyme-linked
LOD
1 U/ml
Calibration
Evaluated
Analysis of cross reactivity
Not evaluated
False positives
1 AU
False negatives
1 AU
Precision
Evaluated
Accuracy
99.11 % IgG
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
94 % IgG
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