SARA-CoV-2 Antigen Rapid Test Kit
Manufactured by Diasia Biomedical Technology Co., Ltd., China - www.diasia.com.cn
Device identification number
1986
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
04/14/2021 05:19
Comments
LOD (U/ml) ：9.975 x 102 TCID50/mL The BFARM list is 573/21
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
15 minutes
LOD
9.9751025 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.71 % (140 specimens were negative by both test reagent and control reagent, and there is 1 specimen of fal
Fn
3.12 % (128 specimens were positive by both test reagent and control reagent, and there are 4 specimens of f
Precision
Not evaluated
Accuracy
98.17 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.97 %
Clinical Specificity
99.29 %
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