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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 (Nasal Swab)

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

Device identification number
2578
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Lineages detected
B.1.617.2 (Delta),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
ACCU-TELL ® COVID-19 Antigen Cassette(Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS- CoV-2 antigen in Nasal swab. The identification is based on monoclonal antibodies specific to the Nucleocapsid(N)protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of COVID-19 infection
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
0.8 % (2/250)
Fn
6.79 % (7/103)
Precision
Evaluated
Accuracy
97.5 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.2 % ((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