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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



QuickVue SARS Antigen FIA

Manufactured by Quidel Corporation, United States - www.quidel.com 

Device identification number
2269
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 P.1 (Gamma),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Accuracy (98,8%) as overall percent agreement with PCR; UK B1.1.7 (D3L+S235F+R230K+S235F+G240R+S235F+S194L) / SA 501Y.V2 (T205I) / UK+SA B.1.1.7/501Y.V2 (D3L+T205I+S235F) / Bra P1 501Y.V3 (I292I+R 203K+G204R+A119S+M234)/ India I/A3I (P13L)/ Delta B.1617.2 (G478K.V1)/ Delta plus AY1 (D63G+D377Y+G215+R230M)
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Fluorescence
LOD
7570 TCID50/ml
Crossreactivity
Evaluated
Fp
0.7 %
Fn
3.4 %
Accuracy
98.45 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.7 %
Clinical Specificity
99.3 %
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