QuickVue SARS Antigen FIA
Manufactured by Quidel Coorporation, 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
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
0.7 %
False negatives
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