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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 Antigen Cassette (Saliva)

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

Device identification number
2580
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-08-27 09:59:59 CET
Comments
ACCU-TELL® COVID-19 Antigen Cassette (Saliva) is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Saliva. The identification is based on the monoclonal antibodies specific for the Nucleocapsid(N)protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of COVID-19 infections.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Other
LOD
1000 TCID50/ml ( )
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % No False positive
Fn
8.21 % (12/146)
Precision
Evaluated
Accuracy
96.1 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.8 % ((Antigen))
Clinical Specificity
99.9 % (>99.9%(Antigen))
Type of antigen
Nucleocapsid protein

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