COVID-19 (SARS-CoV-2) Antigen Test Midstream — Saliva
Manufactured by Anhui Deep Blue Medical Technology Co. Ltd., China - www.dbluemedical.com
Device identification number
2651
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product is used for in vitro qualitative detection of the antigen of SARS-CoV-2 in human saliva specimen. It finished registration in Germany and also in German BfArM List.
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
15 minutes
LOD
80 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.05 %
False negatives
2.5 %
Precision
Evaluated
Accuracy
98.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.5 %
Clinical Specificity
99.5 %
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