COVID-19 Test Kit (Colloidal Gold Method)(for self-testing）
Manufactured by Hangzhou Singclean Medical Products Co. Ltd., China - www.singclean.net
Device identification number
2778
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
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)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Bfarm list AT1259/21 The specimen was Nasal swab.
Assay Type
Immuno-Antigen
Self Test
Yes
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
9.75 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.01 %
False negatives
0.29 %
Precision
Evaluated
Accuracy
99.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.99 %
Clinical Specificity
99.71 %
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