COVID-19 Neutralizing Antibody Testing Cassette(GICA)/COVID-19 Antigen Testing Cassette(GICA)
Manufactured by DN Laboratory Co. Ltd., China
Device identification number
2955
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Semi-automated
Physical Support
Biochip, Fingertip, Microtiter plate
Target type
Antibody, Antigen, IgA, IgG, IgM
Antibody type
Monoclonal
Specimen
Nasal swab, Nasopharyngeal swab, Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
COVID-19 Antigen Testing Cassette (GICA):The Reagent Kit can be used for a qualitative test of COVID-19 antigens in human nasopharyngeal swab and oropharyngeal swab samples in vitro, which is beneficial to the auxiliary examination of patients suffering from pneumonia caused by COVID-19 infection. COVID-19 neutralizing antibody testing cassette (GICA):The Reagent Kit can be used for a qualitative test of COVID-19 neutralizing antibodies in human serum, plasma or whole blood samples in vitro.
Assay Type
Immuno-Antibody
Self Test
Yes
Reader Required
Yes
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Semiquantitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
the positive coincidence rate should be (+/+) 5/5
False negatives
he negative coincidence rate should be (-/-) 10/10
Precision
Evaluated
Accuracy
100 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Specificity
100 % 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