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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

DIAQUICK COVID-19 Ag Cassette

Manufactured by DIALAB GmbH, Austria - www.dialab.at/en/home/ 

Device identification number
1375
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Other
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
It is a twin test of Alltest (ID 1257). The tests are identical in design and construction, but distributed under a different name.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
100 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.34 % (total 2023 negative samples. 7 wrong positive. 2016 correct negative.)
Fn
1.98 % (total 101 positive samples. 99 correct positive. 2 wrong negative)
Precision
Evaluated
Accuracy
99.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.4 % (relative sensitivity)
Clinical Specificity
99.9 % (relative specificity)
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