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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Sofia Flu + SARS Antigen FIA

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

Device identification number
2682
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based, Near POC / POC, Other
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Anterior nasal swab, Nasal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), 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
Further information on detection of SARS CoV-2 variants available from the manufacturer / There were no Influenza PCR-positive specimens at time of clinical evaluation. Thus, sensitivity of the Influenza target could not be calculated / Detection via Immune-Fluorescence
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Fluorescence
LOD
1.9 TCID50/ml (Flu B)
LOD
91.7 TCID50/ml (SARS CoV-2)
LOD
50 TCID50/ml (Flu A)
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % SARS CoV-2 Target
Fp
0 % Flu B-Target
Fp
0 % Flu A-Target
Fn
4.8 % (SARS CoV-2 Target )
Fn
0 % Flu B-Target: no PCR positives at time of clinical study
Fn
0 % Flu A-Target: no PCR positives at time of clinical study
Precision
Not evaluated
Accuracy
100 % (Flu B)
Accuracy
100 % (Flu A)
Accuracy
98.8 % (SARS CoV-2)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.2 % (SARS CoV-2)
Clinical Specificity
100 % (Flu A)
Clinical Specificity
100 % (Flu B)
Clinical Specificity
100 % (SARS CoV-2)
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