SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay)
Manufactured by Shenzhen Biocup Biotech Co. Ltd., China - www.bio-cup.com
Device identification number
1950
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow, Latex
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Shenzhen Biocup Biotech Co., Ltd., established in 2000, is a biomedical high-tech enterprise dedicated to the research, development, production and sales of in vitro diagnostic reagents and medical laboratory instruments. Our company has successively won the honorary titles of "Shenzhen high tech enterprise" and "national high tech enterprise", ISO9000, ISO13485 quality management system certification and CE certification.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
45 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
7 % (The probability of false positive is 7%.)
False negatives
1.18 % (The probability of false negative is 1.18%.)
Precision
Evaluated
Accuracy
95.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 %
Clinical Specificity
98.82 %
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