SARS-CoV-2 & Influenza A/B Antigen Assay Kit (Colloidal Gold Method)
Manufactured by Zybio Inc., China - https://www.zybio.com/en/
Device identification number
2211
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza B, SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
NA
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
AU 50
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
4.25 % ((SARS-CoV-2), 5.26%(Influenza A), 8.33%(Influenza B))
False negatives
0.75 % ( (SARS-CoV-2), 1.06%(Influenza A), 0.3%(Influenza B))
Precision
Evaluated
Accuracy
98.33 % ( (SARS-CoV-2), 98.06%(Influenza A), 99.17%(Influenza B))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.74 % ((SARS-CoV-2), 94.74%(Influenza A), 91.67%(Influenza B))
Clinical Specificity
99.25 % ( (SARS-CoV-2), 98.94%(Influenza A), 99.70%(Influenza B))
Type of antigen
Other
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