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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CoviGnost AG test devices

Manufactured by BioGnost Ltd., Croatia - www.biognost.hr 

Device identification number
2481
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Latex
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
COVID-19 Antigen Rapid Test CoviGnost AG is a qualitative chromatographic immunoassay for detection of SARS-CoV-2 antigens in human nasopharyngeal swab specimens.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.4 % (Total 82 / 2 false positives)
False negatives
1.56 % (Total 192 / 3 false negatives)
Precision
Evaluated
Accuracy
98.2 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.4 %
Clinical Specificity
99 %
Type of antigen
Nucleoprotein

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