Redtest SARS-CoV-2 Antigen Rapid Test (Covid-19 Ag)
Manufactured by Sigmed Sp. z o.o., Poland - https://redtest.eu
Device identification number
2328
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
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
BfArM List of Antigen tests for selftesting (in German)
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
LOD
6 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
0 AU
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Specificity
100 %
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