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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

STANDARD Q COVID-19 Ag Test 

Manufactured by SD BIOSENSOR Inc; Roche

Manufacturer website
CE Marking
Yes
Detection Principle
ImmunoAssay-Antigen
Format
Rapid diagnostic test
Target
Antigen
Commercial Status
Commercialised
Last Update
05/11/2020
Comments
https://www.finddx.org/wp-content/uploads/2020/10/SDQ-Ag-Public-Report_20201016-v1-1.pdf
Test Type
Manual Assay
Test Type Result
Qualitative
Format
Immunochromatography (Test cassette)
Detection Principle Antibody
colorimetry
Specimen
Nasopharyngeal swab
Antigen IgG
N.A
Antigen IgM
N.A
Antigen IgA
N.A
Guidance Available
Yes
Reader
Not Required
Time (Min)
30
Fp
Not found
Fn
Not found
Lod
1981 TCID50 /mL
Analysis of Cross Reactivity
0 for bacteria, virus, parasite tested and interfering substances unless SARS-coronavirus
Robustness
Not Reported
Precision
Not Reported
Calibration
Not Reported
Sensitivity Percent
96,52%
Specificity Percent
99,68%
Accuracy Percent
Not Reported
Reproducibility
Not Reported
Type of Antigen
Not found

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