SARS-CoV-2 Antigen Test Kit (LFIA)
Manufactured by Weihai Dishang Medical Technology Co. Ltd., China - https://dsmedicaltech.com
Device identification number
2804
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Card
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
NA
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
312 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 %
False negatives
6.67 %
Precision
Evaluated
Accuracy
96.05 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.33 %
Clinical Specificity
98 %
Type of antigen
ORF1a protein
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