3gamma COVID-19 IgA / IgM / IgG
Manufactured by Tregena, Italy - www.3gamma.it/
Device identification number
1026
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgA, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
344 RT-PCR-confirmed cases containing 55 positive and 289 negative specimens are tested. The data above are >14 days from symptom onset to blood collectionMade in Taiwan http://www.3gamma.it/1/upload/brochure_3_gamma.pdf
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
Clinical Sensitivity
99 %
Clinical Specificity
95.2 %
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