COVID-19 Antigen Rapid Test Cassette (Swab)
Manufactured by Zhengzhou Fortune Bioscience Co. Ltd., China - www.fortunetest.com
Device identification number
1827
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
We are a professional supplier of in vitro diagnostic products in Henan Province, China. We have experienced in vitro diagnostic personnel and professional team to meet the different needs of customers. For the COVID-19 rapid test product we have series of antibody, antigen and nucleic acid test, and all have obtained CE certification. With a purification workshop of 6000 square meters and a daily output of 300000 people, it can provide customers with one-stop service of COVID-19 Rapid Test.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
LOD
0.01 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
None
False negatives
3.64 %
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.36 %
Clinical Specificity
100 %
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