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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 (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Strip
Target type
Antibody, IgG, IgM
Specimen
Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
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