Dräger COVID-19 Home Test
Manufactured by Dräger Safety AG & Co. KGaA, Germany - www.draeger.com
Device identification number
2647
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
We have updated the section on detected virus variants for ID2647. This update is based on a recent update of the corresponding technical documentation. ID2647 is the home-use version of the professional test ID2273. We have submitted an update to its section on detected virus variants, too. Thank you.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
200 pg
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.32 % (1 out of 308 samples (symptomatic and asymptomatic PCR negative))
False negatives
10.1 % (7 out of 69 samples (overall, symptomatic PCR positive))
Precision
Evaluated
Accuracy
98.9 % (Ct values < 26; 97.1% (overall))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.8 % (Ct values < 26)
Clinical Specificity
99.7 %
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