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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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 (RAT)
×No
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
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
Analysis of cross reactivity
Evaluated
False positives
0.71 % ((140 specimens were negative by both test reagent and control reagent, and there is 1 specimen of fal)
False negatives
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