COVID-19 and Influenza A+B Antigen Combo Test Kit Plus
Manufactured by Wuhan EasyDiagnosis Biomedicine Co. Ltd., China - http://www.easydiagnosis.com.cn/
Device identification number
3987
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Other (Staphylococcus aureus, streptococcus pneumonia, measles, mumps virus, Adenovirus (type 3,C1,71), Mycoplasma pneumonia, parainfluenza virus (1-4), Mycobacterium tuberculosis, Coronavirus OC43, 229E, NL63, HKU1,bordetella pertussis, Influenza B Virus (Victo)
Pathogens detected
Influenza A, Influenza B, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
N.A.
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
500 AU
Analytical Sensitivity
100 %
Analytical Specificity
100 %
False positives
0 %
False negatives
0 %
Accuracy
98.5 %
Clinical Sensitivity
96.15 %
Clinical Specificity
99.26 %
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