SARS-CoV-2 antigen IVD kit SALIVA
Manufactured by Shenzhen Reagent Technology Co. Ltd., China - https://www.reagen.cn/
Device identification number
2295
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
312.5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.58 % (4 false positives were detected in 155 negative samples)
False negatives
10.4 % (11 false negatives were detected in 105 positive samples)
Precision
Evaluated
Accuracy
94.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
89.5 % (（95%CI:76.94%-98.20%）)
Clinical Specificity
97.4 % (（95%CI:86.28%-98.96%）)
Type of antigen
Nucleoprotein
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