Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 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
Crossreactivity
Evaluated
Fp
1.9 % (2 false positives in 105 tests)
Fn
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