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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Accu-Tell COVID-19 IgG/IgM Cassette

Manufactured by AccuBioTech Co. Ltd, China - www.accubiotech.com 

Device identification number
14
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Strip
Target type
Antibody, IgG, IgM
Specimen
Serum, Whole blood
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-08-27 12:10:30 CET
Comments
ACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of SARS-COV-2 infections.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Other
Calibration
Not evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
95.5 % IgG
Accuracy
95.5 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.5 % IgG
Clinical Sensitivity
93.5 % IgM
Clinical Specificity
97.5 % IgG
Clinical Specificity
97.5 % 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