COVID-19 Antigen/FLU A+B Antigen Combo Rapid Test Cassette (Colloidal Gold Method)
Manufactured by Wuhan NanoDiagnosis for Health Biotechnology Co. Ltd., China - ndh-biotech.com
Device identification number
1838
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
LOD: SARS-CoV-2 5×10ˆ2.55 TCID50/mL Influenza A(H1N1): 1.0×103 TCID50/ml Influenza A (H3N2):1.0×103 TCID50/ml Influenza A (H1N1pdm09):5.0×103 TCID50/ml Influenza B (Yamagata):1.0×104 TCID50/ml Influenza B (Victoria):1.0×103 TCID50/ml
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
3581.5 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.9 % (2 false positives in 105 tests)
False negatives
0.6 % (2 false negatives in 331 tests)
Precision
Evaluated
Accuracy
99.08 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.1 %
Clinical Specificity
99.4 %
Type of antigen
Nucleoprotein
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