SARS-CoV-2 Antigen Rapid Qualitative Test
Manufactured by Multibrands Trading(Suzhou) Co. Ltd., China - www.multibrands.eu.com
Device identification number
2534
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
n/a
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Other ()
Method
Immunochromatography
Measurement
N.A.
Time
15 minutes
Subclass
Sandwich
LOD
70 (cfu/ml)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.97 % (3 samples found false positive in total 309 samples)
False negatives
1.44 % (3 samples found flase negative in total 209 samples)
Precision
Evaluated
Accuracy
98.84 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.56 % (Antigen)
Clinical Specificity
99.03 % (Antigen)
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