COVID-19 Antigen/Flu A+B Antigen Combo Rapid Test Cassette
Manufactured by Wuhan NanoDiagnosis for Health Biotechnology Co. Ltd., China - ndh-biotech.com
Device identification number
1756
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
1774 TCID50/ml (SARS-CoV-2 )
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
0 AU
Precision
Evaluated
Accuracy
100 (Antigen)
Robustness
Not evaluated
Clinical Sensitivity
96.88 % (Antigen)
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