Rapid New Coronavirus (COVID19) IgG/IgM Combo Test
Manufactured by Immunospark s.r.l., Italy - www.immunospark.com
Device identification number
1903
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
IgG, IgM
Specimen
Peripheral blood, Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
More information available in detailes report of the technicla file!
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
30 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
A smal amount of results did not correltaed with the reference but correlated with rapid test
False negatives
A smal amount of results did not correltaed with the reference but correlated with rapid test
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Specificity
98 %
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