SARS-CoV-2 Antigen Test Kit (Colloidal Gold) - Saliva
Manufactured by Hipro Biotechnology Co. Ltd., China
Device identification number
2628
CE Marking
✓Yes
HSC common list (RAT)
×No
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 Antigen Test Kit (saliva）(Colloidal Gold) can quickly detect SARS-CoV-2 antigen in saliva by forming visible lines and provide auxiliary diagnosis for Covid-19 infection
Assay Type
Immuno-Antigen
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
130 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.66 % (10/600)
False negatives
1.87 % (5/267)
Precision
Not evaluated
Accuracy
98.27 % ( (95%CI: 97,46%-99,08%))
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.6 % ( (95%CI: 96,04%-99,24%))
Clinical Specificity
97 % ( (95%CI: 96,62%-99,84%))
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