SARS-CoV-2 Antigen Rapid Test Kit
Manufactured by Wuhan UNscience Biotechnology Co. Ltd., China - www.uni-science.com
Device identification number
1600
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Epstein-Barr Virus (EBV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Rhinovirus, SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.2 (Delta), B.1.617.3, C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-10-20 09:28:50 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
Use the LOD national reference S to dilute into three samples of1:400 (S1), 1:800 (S2), and 1:1600 (S3), repeat the determination 3 times, of whichS1 are all positive, S3 are all negative, and S2 results can be positive or negative.
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.43 % (1/231)
False negatives
3.67 % (4/109)
Precision
Evaluated
Accuracy
98.53 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.33 % ((95%CI: 90.870%, 98.991%))
Clinical Specificity
99.569 % ((95%CI: 97.622%, 99.989%))
Type of antigen
Nucleocapsid 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