Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette

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

Device identification number
2581
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Serum, Whole blood
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-12-07 08:55:17 CET
Comments
ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of the presence of neutralizing antibodies to SARS-CoV-2
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Other
Calibration
Not evaluated
Crossreactivity
Not evaluated
Fp
0 % No False positive ( using Elisa kit as the comparator method)
Fn
0 % No False positive ( using Elisa kit as the comparator method)
Precision
Evaluated
Accuracy
100 % ((Neutralizing Antibody))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % ((Neutralizing Antibody))
Clinical Specificity
100 % ((Neutralizing Antibody))

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