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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgG/IgM Rapid Test Cassette

Manufactured by Acro Biotech Inc., United States - www.acrobiotech.com 

Device identification number
465
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colloidal gold
False positives
Evaluated
False negatives
Evaluated
Accuracy
98.6 % IgG
Accuracy
92.9 % IgM
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
85 % IgM
Clinical Specificity
96 % IgM
Clinical Specificity
98 % 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