SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
Manufactured by Shenzhen Uni-medica Technology Co. Ltd., China - www.uni-medica.com
Device identification number
2999
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
Unknown
Specimen
Anterior nasal 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), Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
75-119aa/45-181aa
Commercial Status
Last Update
2022-08-24 09:08:01 CET
Comments
none
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.45 %
False negatives
1.74 %
Precision
Evaluated
Accuracy
99.29 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.26 %
Clinical Specificity
99.56 %
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