Test Rapid IgG/IgM 2019-nCoV
Manufactured by DDS DIAGNOSTIC SRL, Romania - www.ddsdiagnostic.com
Device identification number
1073
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://ddsdiagnostic.com/test-rapid-coronavirus-romania/
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 AU 0
False negatives
0 AU
Precision
Evaluated
Accuracy
98.82 % IgG
Accuracy
98.88 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
100 % IgM
Clinical Specificity
98 % IgG
Clinical Specificity
97.96 % IgM
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