Dräger Antigen Test SARS-CoV-2
Manufactured by Dräger Safety AG & Co. KGaA, Germany - www.draeger.com
Device identification number
2273
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus A, Rhinovirus B, SARS-CoV
Pathogens detected
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
LOD is 200 pg/Test; Osmanodja, B. et al. (2021) ‘Accuracy of a Novel SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Test from Standardized Self-Collected Anterior Nasal Swabs’, Journal of Clinical Medicine, 10(10), p. 2099. doi: 10.3390/jcm10102099. Clinical Validation at Charité, Berlin, Germany
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
200 pg
Calibration
Not evaluated
Analytical Sensitivity
96.8 % ( (Ct values < 26))
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 (symptomatic PCR positive))
Precision
Evaluated
Accuracy
98.9 % (Ct values < 26)
Accuracy
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