SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) （Saliva）
Manufactured by Shenzhen Microprofit Biotech Co. Ltd., China - www.microprofit-bio.com
Device identification number
2606
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
www.microprofit-bio.com
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
49 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
8.7 %
Precision
Evaluated
Accuracy
95.21 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.3 % ((Antigen))
Clinical Specificity
100 % ( (Antigen))
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