GSD NovaLisa® SARS-CoV-2 (COVID-19) quantitative IgG
Manufactured by NovaTec Immundiagnostica GmbH, Germany - https://www.goldstandarddiagnostics.com/home/products/covid-19-elisa-assays/gsd-sars-cov-2-elisa/gsd-sars-cov-2-elisa-igg/
Device identification number
2324
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Microtiter plate
Target type
IgG
Specimen
Other biological fluids, Plasma, Serum
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hemophilus Influenzae, Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The quantitative or qualitative immunoenzymatic determination of specific antibodies is based on the ELISA (Enzyme-linked Immunosorbent Assay) technique. Microtiterplates are coated with specific antigens to bind corresponding antibodies of the sample. After washing the wells to remove all unbound sample material a horseradish peroxidase (HRP) labelled conjugate is added. This conjugate binds to the captured antibodies. In a second washing step unbound conjugate is removed. The immune complex formed by the bound conjugate is visualized by adding Tetramethylbenzidine (TMB) substrate which gives a blue reaction product. The intensity of this product is proportional to the amount of specific antibodies in the sample. Acidic stopping solution is added to stop the reaction. This produces a yellow endpoint colour. Absorbance at 450/620 nm is read using an ELISA Microtiterplate reader.
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
100 minutes
Subclass
Enzyme-linked
LOD
3.6 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3 % ((> 97%))
False negatives
0.51 % ((99.49))
Precision
Evaluated
Accuracy
15 % ((< 15 %))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97 % ((> 97% (15 days post symptom onset)))
Clinical Specificity
99.49 %
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