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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Accu-Tell SARS-CoV-2 Ag Cassette

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

Device identification number
2579
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-10-20 12:48:43 CET
Comments
ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in Nasopharyngeal swab. 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
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Other
LOD
1000 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.82 % (3/363)
Fn
4.27 % (5/117)
Precision
Evaluated
Accuracy
98.3 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.7 % ((Antigen))
Clinical Specificity
99.2 % ((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